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McKesson Syringe 60CC, Luer Lock Tip, Sterile recallZ-2940-2024 · Cypress Medical Products LLC · initiated Jul 24, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cypress Medical Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Affected syringes lack FDA clearance.

FDA root cause category: Other

What the company is doing

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].

Recall details

Recall number
Z-2940-2024
Status
Open, Classified
Initiated by the company
Jul 24, 2024
Posted by the FDA
Aug 29, 2024
Recalling firm
Cypress Medical Products LLC
Quantity
24,693,200 eaches (US)
Product code
FMF
FDA submissions
K103830
Distribution
US distribution only. Domestic distribution nationwide.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K103830 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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