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Recall Observatory FDA recall evidence

Device product

McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)

Z-2940-2024

July 24, 2024

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 95041
Status
Ongoing
Classification
Class II
Quantity
24,693,200 eaches (US)
Official record key
device-enforcement:Z-2940-2024

Official wording

Reason: Affected syringes lack FDA clearance.

Code information: 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

Distribution pattern: US distribution only. Domestic distribution nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Affected syringes lack FDA clearance.