3-Way Standardbore Stopcock — Class II medical device recall Z-0682-2018
Terminated recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., reported 2018-02-28. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because
| Recall number | Z-0682-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., Dover, NH, United States |
| Recall initiated | 2017-07-24 |
| Classified | 2018-02-21 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2019-11-07 |
| Quantity | 200 units |
| Reason classes | sterility, packaging |
| Lot numbers | 1706064D |
Product
3-Way Standardbore Stopcock. Product Code: AMS-100.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0682-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.