Resource Optimization & Innovation Llc
Medical device manufacturer in Saint Louis, MO.
0510(k) clearances
0PMA approvals
226recalls
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-0950-2022 Class II | Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access…A kit component, the PDI Prevantics Swab, was recalled. | 02/28/2022Terminated |
| Z-2699-2020 Class II | regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG -…The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not… | 06/17/2020Terminated |
| Z-2369-2020 Class II | Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush…There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and… | 05/04/2020Terminated |
| Z-2368-2020 Class II | Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush…There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and… | 05/04/2020Terminated |
| Z-0169-2018 Class II | Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended…Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml… | 09/25/2017Open, Classified |
| Z-1678-2017 Class II | Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1677-2017 Class II | Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St FrancisCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1676-2017 Class II | Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1675-2017 Class II | Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1674-2017 Class II | Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1673-2017 Class II | Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1672-2017 Class II | Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - CabriniCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1671-2017 Class II | Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - CabriniCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1670-2017 Class II | Regard, Item Number: 800508004, Sterile, LD0586D - C Section - JasperCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1669-2017 Class II | Regard, Item Number: 800508004, Sterile, LD0586D - C Section - JasperCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1668-2017 Class II | Regard, Item Number: 800508003, Sterile, LD0586C - C Section - JasperCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1667-2017 Class II | Regard, Item Number: 800508002, Sterile, LD0586B - C Section - JasperCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1666-2017 Class II | Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1665-2017 Class II | Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1664-2017 Class II | Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1663-2017 Class II | Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1662-2017 Class II | Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1661-2017 Class II | Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1660-2017 Class II | Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1659-2017 Class II | Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1658-2017 Class II | Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1657-2017 Class II | Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1656-2017 Class II | Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1655-2017 Class II | Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1654-2017 Class II | Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1653-2017 Class II | Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1652-2017 Class II | Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1651-2017 Class II | Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1650-2017 Class II | Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1649-2017 Class II | Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1648-2017 Class II | Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1647-2017 Class II | Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1646-2017 Class II | Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1645-2017 Class II | Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1644-2017 Class II | Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1643-2017 Class II | Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1642-2017 Class II | Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1641-2017 Class II | Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1640-2017 Class II | Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1639-2017 Class II | Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1638-2017 Class II | Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1637-2017 Class II | Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1636-2017 Class II | Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus HighlandCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1635-2017 Class II | Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus HighlandCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1634-2017 Class II | Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa…Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1633-2017 Class II | Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa…Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1632-2017 Class II | Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1631-2017 Class II | Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - AlamoCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1630-2017 Class II | Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - AlamoCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1629-2017 Class II | Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1628-2017 Class II | Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1627-2017 Class II | Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1626-2017 Class II | Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1625-2017 Class II | Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1624-2017 Class II | Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1623-2017 Class II | Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1622-2017 Class II | Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1621-2017 Class II | Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1620-2017 Class II | Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1619-2017 Class II | Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1618-2017 Class II | Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa…Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1617-2017 Class II | Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa…Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1616-2017 Class II | Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1615-2017 Class II | Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1614-2017 Class II | Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1613-2017 Class II | Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1612-2017 Class II | Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1611-2017 Class II | Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1610-2017 Class II | Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1609-2017 Class II | Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa…Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1608-2017 Class II | Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa…Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1607-2017 Class II | Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1606-2017 Class II | Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1605-2017 Class II | Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1604-2017 Class II | Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1603-2017 Class II | Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New BraunfelsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1602-2017 Class II | Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New BraunfelsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1601-2017 Class II | Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1600-2017 Class II | Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1599-2017 Class II | Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1598-2017 Class II | Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1597-2017 Class II | Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1596-2017 Class II | Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1595-2017 Class II | Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1594-2017 Class II | Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1593-2017 Class II | Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1592-2017 Class II | Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1591-2017 Class II | Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1590-2017 Class II | Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1589-2017 Class II | Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1588-2017 Class II | Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1587-2017 Class II | Regard, Item Number: 800508001, Sterile, LD0586A - C Section - JasperCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1586-2017 Class II | Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1585-2017 Class II | Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1584-2017 Class II | Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1583-2017 Class II | Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1582-2017 Class II | Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1581-2017 Class II | Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1580-2017 Class II | Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1579-2017 Class II | Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1578-2017 Class II | Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1577-2017 Class II | Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1576-2017 Class II | Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1575-2017 Class II | Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1574-2017 Class II | Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1573-2017 Class II | Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1572-2017 Class II | Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1571-2017 Class II | Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1570-2017 Class II | Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1569-2017 Class II | Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1568-2017 Class II | Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1567-2017 Class II | Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1566-2017 Class II | Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1565-2017 Class II | Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1564-2017 Class II | Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1563-2017 Class II | Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1562-2017 Class II | Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1561-2017 Class II | Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1560-2017 Class II | Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1559-2017 Class II | Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1558-2017 Class II | Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1557-2017 Class II | Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1556-2017 Class II | Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of AngelsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1555-2017 Class II | Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of AngelsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1554-2017 Class II | Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St FrancisCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1553-2017 Class II | Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover HillsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1552-2017 Class II | Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSUCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1551-2017 Class II | Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1549-2017 Class II | Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - SpohnCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1547-2017 Class II | Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1546-2017 Class II | Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa RosaCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1545-2017 Class II | Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New BraunfelsCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-1544-2017 Class II | Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus HighlandCustom procedure trays contain a component, a light glove, that has been recalled by the manufacturer… | 01/09/2017Terminated |
| Z-0229-2016 Class II | Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays…The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction… | 08/25/2015Terminated |
| Z-0191-2016 Class II | Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0190-2016 Class II | Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0189-2016 Class II | Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0188-2016 Class II | Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0187-2016 Class II | Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0186-2016 Class II | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0185-2016 Class II | Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0184-2016 Class II | Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-2799-2015 Class II | Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used…Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility… | 08/19/2015Terminated |
| Z-2798-2015 Class II | Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in…Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility… | 08/19/2015Terminated |
| Z-0104-2016 Class II | regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0103-2016 Class II | regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0102-2016 Class II | regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0101-2016 Class II | regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0100-2016 Class II | regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0099-2016 Class II | regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0098-2016 Class II | regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0097-2016 Class II | regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0096-2016 Class II | regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0095-2016 Class II | regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0094-2016 Class II | regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0093-2016 Class II | regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0092-2016 Class II | regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0091-2016 Class II | regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0090-2016 Class II | regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0089-2016 Class II | regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0088-2016 Class II | regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0087-2016 Class II | regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0086-2016 Class II | regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0085-2016 Class II | regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0084-2016 Class II | regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0083-2016 Class II | regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0082-2016 Class II | regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0081-2016 Class II | regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0080-2016 Class II | regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0079-2016 Class II | regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0078-2016 Class II | regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0077-2016 Class II | regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0076-2016 Class II | regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0075-2016 Class II | regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0074-2016 Class II | regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0073-2016 Class II | regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0072-2016 Class II | regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0071-2016 Class II | regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0070-2016 Class II | regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0069-2016 Class II | regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0068-2016 Class II | regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0067-2016 Class II | regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0066-2016 Class II | regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0065-2016 Class II | regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0064-2016 Class II | regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0063-2016 Class II | regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0062-2016 Class II | regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0061-2016 Class II | regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0060-2016 Class II | regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0059-2016 Class II | regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0058-2016 Class II | regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0057-2016 Class II | regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0056-2016 Class II | regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0055-2016 Class II | regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0054-2016 Class II | regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |