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Recall Observatory FDA recall evidence

Device product

Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304

Z-1843-2022

August 16, 2022

Class II

Product summary

Firm
Cook Incorporated
Event
Event 90793
Status
Ongoing
Classification
Class II
Quantity
149 US
Official record key
device-enforcement:Z-1843-2022

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: STF-18-40-AUST G07304 UDI-DI: 00827002073043 Lots/Expiration Date: 14788615 13-06-2027 14816230 28-06-2027 14836977 12-07-2027

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.