Cook, Inc. Recalls Various Medical Device Sets Due to Incorrect Expiration Dates

What Happened

Cook, Incorporated has issued a recall for several medical device sets because the product labels display incorrect expiration dates. An internal investigation determined that errors occurred during the process of setting expiration dates based on the earliest expiring component. This resulted in some products being labeled with shelf-lives that are longer than their actual validated duration.

Which Products Are Affected

The recall involves several device types and specific lot numbers, including the Approach® CTO Micro Wire Guide and Wayne Pneumothorax Set. Specific lot and model details provided include:

Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set

• Lot 15151627 (Model C-PTIS-100-UNL-HC-G-EU)
• Lot 16189597 (Model C-PTIS-100-HC-G-EU)
• Lot 16175956 (Model C-PTIS-100-HC-G-EU)
• Lot 16175949 (Model C-PTIS-100-UNS-HC-G-EU)

Cook Five Lumen Central Venous Catheter Set

• Lot 15478180 (Model C-UQLM-1001J-ABRM-HC-RD)

Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial

• Lot 16532975 (Model C-UTLM-701J-ABRM-HC-RD-CAH)
• Lot NS15660282 (Model C-UTLM-501J-ABRM-HC-CAH)
• Lot 15687199 (Model C-UTLM-701J-RSC-ABRM-HC-RD-CAH)
• Lot NS15597521 (Model C-UTLM-501J-PED-ABRM-HC)

What You Should Do

Healthcare facilities and consumers should immediately check their inventory for the affected lot and model numbers. If affected products are found, they should not be used. For more information, contact Cook, Incorporated at 750 Daniels Way, Bloomington, Indiana, 47404.

Why This Matters

Using medical devices beyond their intended shelf-life can lead to component degradation or loss of sterility, which may pose risks to patient health.

Source

This recall is based on information provided by Health Canada.