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Recall Observatory FDA recall evidence

Device product

Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476

Z-1832-2022

August 16, 2022

Class II

Product summary

Firm
Cook Incorporated
Event
Event 90793
Status
Ongoing
Classification
Class II
Quantity
58 US; 5 OUS
Official record key
device-enforcement:Z-1832-2022

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: THSCF-25-180-3 G02165 UDI-DI: 00827002021655 Lots/Expiration Dates: 14797761 16-06-2027 14813704 27-06-2027 TSCF-25-80-3 G00476 UDI-DI: 00827002004764 Lots/Expiration Dates: NS14797766 16-06-2027 NS14807600 22-06-2027 NS14821727 30-06-2027

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.