Recall Z-1560-2017
Resource Optimization & Innovation Llc · initiated January 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
Codes / lots: 037321B Exp Date 2018-08-12
Reason for recall
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
FDA-determined cause: Nonconforming Material/Component
Action taken
ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.
Details
- Recall number
- Z-1560-2017
- Initiated
- January 9, 2017
- Terminated
- September 28, 2018
- Product code
- LRO – General Surgery Tray
- Quantity
- 30 kits
- Distribution
- US Distribution to LA and TX.
- Recalling firm
- Resource Optimization & Innovation Llc, Springfield, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |