AMS-636 — Class II medical device recall Z-1484-2017
Terminated recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., reported 2017-03-29, distributed nationwide. Incorrect priming volume printed on the device package.
| Recall number | Z-1484-2017 |
|---|---|
| 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 | 2017-02-20 |
| Classified | 2017-03-18 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2019-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 30,700 |
Product
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Reason for recall
Incorrect priming volume printed on the device package.
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-1484-2017. 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.