Churchill Medical Systems 3-Way Stopcock Recall: Risk of Contaminated Sterility
Churchill Medical Systems recalls 3-Way Standardbore Stopcocks (AMS-10:1706064D) due to potential gaps in packaging adhesive that could compromise sterility. Affected users should contact the company for details.
Lower-risk recall
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
Contact the company
What happened, in plain English
Churchill Medical Systems is recalling 3-Way Standardbore Stopcocks with product code AMS-100 and lot number 1706064D because their Tyvek packaging may have gaps in adhesive, risking contamination. This could affect medical procedures requiring sterile equipment. Read more at govinfonow.com/recall/73362-churchill-medical-systems-3-way-stopcock-recall-risk-of-contaminated.
Source Summary by GovInfoNow · govinfonow.com/recall/73362-churchill-medical-systems-3-way-stopcock-recall-risk-of-contaminated · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0682-2018
Cite this page
“Churchill Medical Systems 3-Way Stopcock Recall: Risk of Contaminated Sterility.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73362-churchill-medical-systems-3-way-stopcock-recall-risk-of-contaminated. Based on FDA recall #Z-0682-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0682-2018%22&limit=1).
Why it’s dangerous
The stopcocks' Tyvek packaging may not seal properly due to incomplete adhesive coating. This could create gaps that allow contamination, potentially compromising the sterility of medical equipment during procedures.
Who’s affected
Healthcare professionals using these stopcocks for medical procedures are most at risk. Patients receiving procedures with contaminated equipment could be affected.
How to tell if you have this one
Check for product code AMS-100 and lot number 1706064D on the stopcock. The recall covers specific products made by Churchill Medical Systems.
- Brand
Churchill Medical Systems- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
U.S.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0678-2018 | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M; Lot Number: 1705060D | N/A |
| Z-0679-2018 | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.; Lot Number: 1706017D | 396 units |
| Z-0680-2018 | CVC Tray Pediatrics. Product Code: AMS-9335CP-2.; Lot Number: 1706044D | 300 units |
| Z-0681-2018 | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910.; Lot Number: 1706049D | 156 |
| Z-0682-2018 | 3-Way Standardbore Stopcock. Product Code: AMS-100.; Lot Number: 1706064D | 200 units |
What to do — step by step
Contact Manufacturer
Reach out to Churchill Medical Systems for specific instructions on handling the recalled stopcocks.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.3 years 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-0682-2018 (July 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0682-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 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.