Cook Incorporated recalls Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set after lots were labeled with expiration dates that exceed true shelf life. The recall affects two reference parts with multiple UDI and lot numbers. Healthcare facilities should stop use and follow recall instructions.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is used to establish a temporary airway in emergency medical situations when conventional airway access is not possible.
Expired labeling may misrepresent shelf life, potentially compromising device integrity and effectiveness during urgent procedures.
This recall is not described as part of a broader pattern in the provided data.
Immediate cessation of use is required. Hospitals and clinics must verify lot numbers and halt use of affected units; replacements or refunds will follow the manufacturer’s process.
Manufacturer packaging and labeling show part numbers and lot numbers
Recall process timelines vary; expect several weeks for replacements or refunds
Maintain recall notices, batch records, and correspondence with Cook Incorporated
Brand: Cook Incorporated. Product: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set. Reference Part Numbers: C-TCCSB-500-UNI (Order G32193) and C-TCCSB-500-UNI-01 (Order G47665). Lot numbers include NS16189671 and 16191666, 16191661, 16191677, 16191668, 16191666, 16191677, 16195472, 16195467, 16191666. UDI entries provided for each reference. Quantity: 476 units. Distribution: Worldwide. Recall date: 2026-03-05. Status: Active.
No specific injuries or incidents are reported in the provided data.
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