Z-2940-2024Class II
McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX...
Cypress Medical Products LLC / initiated 2024-07-24 / Open, Classified
Cypress Medical Products LLC began a recall of McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS) on . FDA classified it as Class II and gives the reason as "Affected syringes lack FDA clearance". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2940-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Cypress Medical Products LLC
- Product
- McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
- Product code
- FMF Syringe, Piston
- Reason for recall
- Affected syringes lack FDA clearance.
- FDA 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 [email protected].
- Quantity in commerce
- 24,693,200 eaches (US)
- Distribution
- US distribution only. Domestic distribution nationwide.
- Product codes and lots
- All lots of the affected product 102-S60C, SYRINGE, LL 60CC which are within their expiration date, are being recalled. Products were manufactured within the last five years. Affected lots: All lots beginning with alpha characters CLN. UDI-DI (01)30612479170316
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2940-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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