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Recall Observatory FDA recall evidence

Device product

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

Z-1845-2022

August 16, 2022

Class II

Product summary

Firm
Cook Incorporated
Event
Event 90793
Status
Ongoing
Classification
Class II
Quantity
No distribution (Distribution Center only)
Official record key
device-enforcement:Z-1845-2022

Official wording

Reason: 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.

Code information: THSF-35-125-THG G27031 UDI-DI: 00827002270312 Lot/Expiration Date: 14804788 21-06-2027 THSF-35-145-THG G27033 UDI-DI: 00827002270336 Lots/Expiration dates: 14804789 21-06-2027 NS14804743 21-06-2027

Distribution pattern: Domestic distribution nationwide. Foreign distribution worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.