Amplatz extra Stiff Wire Guide recall: Sterility Concern
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
Why was Amplatz extra Stiff 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?
THSF-35-145-AES-SGH (GPN G06801) - UDI (01)00827002068018(17)270602(10)14767453 - Lot 14767453, Expiration Date 02-06-2027 THSF-38-80-AES-SGH (GPN G06874) - UDI (01)00827002068742(17)270620(10)14802152 - Lot 14802152, Expiration Date 20-06-2027
- Product
- Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
- Recalling firm
- Cook Incorporated
- Quantity
- 204 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)