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Recall Observatory FDA recall evidence

Device product

Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561

Z-1836-2022

August 16, 2022

Class II

Product summary

Firm
Cook Incorporated
Event
Event 90793
Status
Ongoing
Classification
Class II
Quantity
42 US
Official record key
device-enforcement:Z-1836-2022

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: TSFNA-35-145 G00701 UDI-DI: 00827002007017 Lots/Expiration Date: 14798674 16-06-2027 TSCFNA-35-145-3 G00561 UDI-DI: 00827002005617 Lots/Expiration Date: 14835600 11-07-2027

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.