Fixed Core Wire Guide recall: Foreign Material
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To…
Why was Fixed Core Wire Guide recalled?
Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931
- Product
- Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To…
- Recalling firm
- Cook Inc.
- Quantity
- 61 units
- Distribution
- US distribution to AZ, IA, IN, MA, and ND.
- Recall date
- November 11, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)