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Recall Observatory FDA recall evidence

Device product

Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)

Z-1825-2022

August 16, 2022

Class II

Product summary

Firm
Cook Incorporated
Event
Event 90793
Status
Ongoing
Classification
Class II
Quantity
488 US, 5 OUS
Official record key
device-enforcement:Z-1825-2022

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: TSFBP-35-180 (GPN G09782) UDI-DI 00827002097827, Lots 14797763 14797770 14805076 14805079 14813709 14813711; TSFBP-35-145 (GPN G09735) UDI-DI 00827002097353, Lots 14807595 14812037 14812038

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.