FDA-Device2026-04-15Class IIMISBRANDING

Cook Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set recalled for incorrect expiration dates

EXPIRATION DATE ERRORNationwide distribution

Check Cook Melker catheter set expiration dates

Cook Incorporated discovered that certain lots of the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set were labeled with expiration dates longer than the actual shelf life of the product. This means some units may have been used past their true expiration date, potentially affecting sterility and safety.

  • If you have this device, check the lot number and reference part number against the FDA recall list
  • Do not use the product if it matches a recalled lot number
  • Contact Cook Incorporated or your supplier for instructions on replacement or return
  • Verify expiration dates on any remaining inventory before use
Hazard

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Sold states
Worldwide distribution.
Affected count
476 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2026

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