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General Purpose Syringe McKesson 60 mL Luer Lock Tip… recallZ-3154-2024 · Cypress Medical Products LLC · initiated Aug 6, 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

The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.

FDA root cause category: Process control

What the company is doing

An Urgent Product Recall Notification letter dated 8/6/24 was sent to customers. Actions to be Taken 1. Immediately quarantine and discontinue use of any product matching the affected items and lot numbers listed above. Affected items should be destroyed on location per appropriate local, state, and federal disposal requirements. 2. Please complete and return the enclosed response form (Attachment #1) as soon as possible, even if you do not have any product on hand or have already consumed the product. Return completed form to [email protected]. 3. If you have further distributed this product to end users, please notify them immediately of this urgent product recall and ask them to segregate and quarantine this product immediately. You are encouraged to include a copy of this notification letter in your communication with any of these end users. If you have questions regarding this notification, please contact McKesson directly by phone at (800) 688-8840 or email [email protected]. Representatives are available Monday Friday, 8:00 am 5:00 pm PST.

Recall details

Recall number
Z-3154-2024
Status
Open, Classified
Initiated by the company
Aug 6, 2024
Posted by the FDA
Sep 16, 2024
Recalling firm
Cypress Medical Products LLC
Quantity
3 Boxes (25 per box, 75 total units)
Product code
FMF
Distribution
US Nationwide distribution in the states of CA, NV, NY.

Product description

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

Code information (models, lots, serial numbers)

UDI-DI: 20612479170302;

Devices named in this recall

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

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page