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Moderate riskFDA DeviceClass II

Cook Medical NCompass Nitinol Stone Extractor recalled for incorrect expiration dating

Cook Medical's NCompass Nitinol Stone Extractor devices in certain lots were labeled with expiration dates that go beyond the actual shelf life of the product. This affects 70 units distributed worldwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Cook recalls

What to do

  1. Check your Cook Medical NCompass stone extractor for Lot Number 15741134 or 15855141
  2. Verify the labeled expiration date against the product's true shelf life before use
  3. Contact Cook Medical or your supplier if you have affected devices
  4. Do not use the device beyond its actual shelf life
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
70 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1787-2026

In the FDA's words

Description
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-NTSE-2.4-115-NC3, UDI (01)00827002362505(17)261103(10)15741134, Lot Number 15741134; Reference Part Number C-NTSE-2.4-115-NCT4, UDI (01)00827002362512(17)270118(10)15855141, Lot Number 15855141. Distribution: Worldwide distribution. Affected quantity: 70 units
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

18 products in this recall

Cook Medical procedure kits recalled for expiration date errors

Cook Medical is recalling 18 product listings, including catheter, tracheostomy, and central venous kits and trays, because some affected lots were labeled with expiration dates longer than their true shelf life. No injuries have been reported, and the products were distributed worldwide.

The agency lists each product separately. Check every one you might have.

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Expiration date errorMedical devicesSold nationwideMore from FDA Device