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Moderate riskFDA DeviceClass II

Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates

Cook Medical's Wayne Pneumothorax Set (certain lot numbers) was labeled with expiration dates that go beyond when the device is actually safe to use. This affects 104 units distributed worldwide. No injuries have been reported.

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

What to do

  1. Check if you have a Cook Medical Wayne Pneumothorax Set with lot numbers 15719344X, 15714808X, 15834145, or 15834147
  2. Do not use the device past its true shelf life, which is earlier than the label states
  3. Contact Cook Medical or your supplier for guidance on replacement or disposal
  4. Verify the lot number on the package before use
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
104 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1791-2026

In the FDA's words

Description
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147. Distribution: Worldwide distribution. Affected quantity: 104 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