Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-2940-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2940-2024Class IIOngoingVoluntary: Firm initiated