FDA-Device2026-04-15Class IIMISBRANDING

Cook Medical Staged Extubation Set recalled for incorrect expiration dates

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

Cook Medical's Staged Extubation Set (Part Number C-CAE-14.0-83-EXTU, Lot 16010654) was labeled with expiration dates that go beyond when the device is actually safe to use. About 95 units were distributed worldwide. No injuries have been reported.

  • Check your inventory for Lot Number 16010654
  • Do not use units beyond their true shelf life
  • Contact Cook Medical or your distributor for guidance on affected units
  • Verify actual product shelf life with the manufacturer 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
95 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1782-2026

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