Cook recalls Fixed Core Wire Guide RPN TSCF-35-260-3 with possible bent wire or loose foreign matter from manufacturing defects.
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.
Cook is recalling a specific medical wire guide due to manufacturing defects that could cause it to bend or have loose foreign matter. This poses a risk during medical procedures where the wire guide is used.
During manufacturing, the wire guide may bend or have loose foreign matter. This could interfere with proper medical device insertion during vascular procedures.
Medical professionals who use this wire guide for vascular procedures may be affected. The risk is low as the defect occurs during manufacturing but does not cause immediate harm.
Check for the model number RPN TSCF-35-260-3 and lot number 13199931. The product has a PTFE coating and is made of stainless steel.
Verify the model number RPN TSCF-35-260-3 and lot number 13199931 on the product label.
The recall indicates a possible manufacturing defect that could cause bending or loose foreign matter, but it does not state that the product is dangerous to use in normal conditions.
Check for the model number RPN TSCF-35-260-3 and lot number 13199931 on the product label.
The recall does not specify a remedy, so no action is required beyond checking if you have the recalled model and lot numbers.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0399-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0399-2021 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
