FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Wayne Pneumothorax Tray recalled for incorrect expiration dates
What this means
Cook Medical's Wayne Pneumothorax Tray kits in certain lots were labeled with expiration dates that go beyond when the devices are actually safe to use. This affects 318 units distributed worldwide. No injuries have been reported.
- Check your inventory for the affected lot numbers: 15719344X, 15714808X, 15834145, or 15834147
- Do not use trays from these lots past their true shelf life, which is earlier than the label states
- Contact Cook Medical for instructions on return or replacement of affected units
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
318 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1792-2026Want us to check the next one for you?
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