PlainRecalls
FDA Devices Moderate Class II Ongoing

Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898

Reported: October 5, 2022 Initiated: August 16, 2022 #Z-1844-2022

Product Description

Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898

Reason for Recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Details

Recalling Firm
Cook Incorporated
Units Affected
240 US; 108 OUS
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898. Recalled by Cook Incorporated. Units affected: 240 US; 108 OUS.
Why was this product recalled?
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1844-2022.