Windstone Medical Surgical Kits Recall: Sterile Barrier Risk
Windstone Medical recalls sterile surgical kits AMS6357 with potential sterile barrier breach. Affected kits include Lot #109138. Stop using immediately to avoid infection risks.
Stop using this now
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/72729-windstone-medical-surgical-kits-recall-sterile-barrier-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72729-windstone-medical-surgical-kits-recall-sterile-barrier-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0069-2018
Cite this page
“Windstone Medical Surgical Kits Recall: Sterile Barrier Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72729-windstone-medical-surgical-kits-recall-sterile-barrier-risk. Based on FDA recall #Z-0069-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0069-2018%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for the product name 'AMS6357' and lot number '109138' on the packaging. These kits were manufactured by Windstone Medical Packaging, Inc.
- Brand
Windstone Medical- Category
Medical device
What to do — step by step
Stop Using Immediately
Discard the affected surgical kits to prevent potential infection risks.
Where it went and when
Where it was distributed
Distributed in South Carolina.
FDA distribution: “US Distribution to the state of : SC” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: South Carolina.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0069-2018 (October 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0069-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.