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Cook Incorporated Recall 90793

Description: Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476

Cook Incorporated Recall 90793 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1832-2022
Event ID90793
Event DescriptionFixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Product TypeDevices
DistributionDomestic distribution nationwide. Foreign distribution worldwide.
Quantity58 US; 5 OUS
Recall ReasonCook 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.
Device Classification20221005
Device Code InfoTHSCF-25-180-3 G02165 UDI-DI: 00827002021655 Lots/Expiration Dates: 14797761 16-06-2027 14813704 27-06-2027 TSCF-25-80-3 G00476 UDI-DI: 00827002004764 Lots/Expiration Dates: NS14797766 16-06-2027 NS14807600 22-06-2027 NS14821727 30-06-2027
Center Classification Date20220928
Recall Initiation Date20220816
Recalling FirmCook Incorporated
Initial Notification Letter
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