PlainRecalls
FDA Devices Moderate Class II Ongoing

Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033

Reported: October 5, 2022 Initiated: August 16, 2022 #Z-1845-2022

Product Description

Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033

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
No distribution (Distribution Center only)
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033. Recalled by Cook Incorporated. Units affected: No distribution (Distribution Center only).
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-1845-2022.