ClearanceBrief
Recall Z-1785-2026 ยท BWC Needle, Emergency Airway

Cook Incorporated

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.

DateApr 6, 2026 (initiated Mar 5, 2026)
StatusOpen, Classified
ReasonProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Root causeIncorrect or no expiration date
ActionCook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowled
Quantity476 units
DistributionWorldwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K010016MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
Cook, Inc., Oct 9, 2001
K160200Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
Cook Incorporated, Feb 17, 2017