FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates
What this means
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.
- Check if you have a Cook Medical Wayne Pneumothorax Set with lot numbers 15719344X, 15714808X, 15834145, or 15834147
- Do not use the device past its true shelf life, which is earlier than the label states
- Contact Cook Medical or your supplier for guidance on replacement or disposal
- Verify the lot number on the package before use
The agency's original wording
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
104 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1791-2026Want us to check the next one for you?
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