Recall Z-1608-2022
Mckesson Medical-Surgical Inc. Corporate Office · initiated May 25, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
Codes / lots: GTIN: 50707387462593; 00707387462598 EA
Reason for recall
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
FDA-determined cause: Environmental control
Action taken
Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
Details
- Recall number
- Z-1608-2022
- Initiated
- May 25, 2022
- Posted by FDA
- August 26, 2022
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 8 cases
- Distribution
- US Nationwide
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1583-2022 Class II | a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1584-2022 Class II | Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1585-2022 Class II | HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1586-2022 Class II | a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1587-2022 Class II | a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum /…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1588-2022 Class II | Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1589-2022 Class II | Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN)…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1590-2022 Class II | a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number:…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1591-2022 Class II | Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1592-2022 Class II | B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1593-2022 Class II | Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1594-2022 Class II | Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1595-2022 Class II | Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1596-2022 Class II | Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1597-2022 Class II | MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1598-2022 Class II | Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1599-2022 Class II | a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1600-2022 Class II | MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1601-2022 Class II | a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1602-2022 Class II | NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1603-2022 Class II | Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1604-2022 Class II | TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1605-2022 Class II | STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1606-2022 Class II | a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1607-2022 Class II | GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1609-2022 Class II | MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1610-2022 Class II | MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number:…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1611-2022 Class II | MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1612-2022 Class II | Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number:…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |
| Z-1613-2022 Class II | Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | 05/25/2022Open, Classified |