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Recall Observatory FDA recall evidence

Device product

Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607

Z-1838-2022

August 16, 2022

Class II

Product summary

Firm
Cook Incorporated
Event
Event 90793
Status
Ongoing
Classification
Class II
Quantity
277 US; 138 OUS
Official record key
device-enforcement:Z-1838-2022

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: RFSPC-35-145 G09607 UDI-DI: 00827002096073 Lot/Expiration Date: 14831437 07-07-2025 14831438 07-07-2025 14835040 11-07-2025 14840287 13-07-2025 14840288 13-07-2025 14840309 13-07-2025

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.