Recall Z-2940-2024 ยท FMF Syringe, Piston
Cypress Medical Products LLC
McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
| Date | Aug 29, 2024 (initiated Jul 24, 2024) |
| Status | Open, Classified |
| Reason | Affected syringes lack FDA clearance. |
| Root cause | Other |
| Action | On July 24, 2024, the firm issued Urgent Medical Device Recall letters to affected customers. Consignees were advised that the affected syringes lack FDA clearance. Customers should immediately quarantine and discontinue use of any affected product. Recalled product should be destroyed on location. If you have further distributed the product, please notify your downstream accounts of the recall. For questions about this notification please contact productcomplaint@McKesson.com. |
| Quantity | 24,693,200 eaches (US) |
| Distribution | US distribution only. Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103830 | JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) Jiangsu Shenli Medical Production Factory, Jul 29, 2011 |