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Recall Observatory FDA recall evidence

Device product

Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677

Z-1847-2022

August 16, 2022

Class II

Product summary

Firm
Cook Incorporated
Event
Event 90793
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1847-2022

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: TMT-35-145 G01677 UDI-DI: 00827002016774 Lot/Expiration Date: 14808818 22-06-2027

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.