Fixed Core Wire Guide recall: Sterility Concern
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Why was Fixed Core Wire Guide recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
THSCF-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
- Product
- Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
- Recalling firm
- Cook Incorporated
- Quantity
- 58 US; 5 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)