Windstone Medical recalls sterile surgical kits AMS6357 with potential sterile barrier breach. Affected kits include Lot #109138. Stop using immediately to avoid infection risks.
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Windstone Medical is recalling sterile surgical kits (AMS635:109138) due to a potential sterile barrier breach. This could lead to infections if used improperly. Affected kits were sold with a specific lot number.
The surgical kits contain a specific catheter component (part #63310) that was previously recalled by CR Bard for a potential sterile barrier breach. This breach could allow contaminants to enter the surgical site during procedures.
Medical professionals and surgical facilities that purchased the AMS6357 kits with Lot #109138 are most at risk. Patients using these kits could face infection risks.
Check for the product name 'AMS6357' and lot number '109138' on the packaging. These kits were manufactured by Windstone Medical Packaging, Inc.
Discard the affected surgical kits to prevent potential infection risks.
The kits contain a catheter component (part #63310) previously recalled by CR Bard for a potential sterile barrier breach.
Lot #109138
Check for the product name 'AMS6357' and lot number '109138' on the packaging.
We’ve drafted a message you can send Windstone Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0069-2018 — Windstone Medical Windstone Medical Hello, I own a Windstone Medical that is covered by recall Z-0069-2018 from Windstone Medical. 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.
