Movable Core Wire Guide recall: Sterility Concern
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Why was Movable 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?
TCMTNA-35-145-3 G01678 UDI-DI: 00827002016781 Lots/Expiration Dates: 14808819 22-06-2027 NS14821223 30-06-2027 NS14851713 21-07-2027
- Product
- Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
- Recalling firm
- Cook Incorporated
- Quantity
- No distribution (Distribution Center only)
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)