FDA Device recall Z-0787-2017
AMS-651, 120" Microbore extension set with slide clamp
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of AMS-651, 120" Microbore extension set with slide clamp by Vygon Mfg Dba Churchill Medical Systems, citing incorrect priming volume is printed on the device package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0787-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-18 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vygon Mfg Dba Churchill Medical Systems |
| Distribution | CA |
Product
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Reason
Incorrect priming volume is printed on the device package.
Identifiers
| code_info | 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0787-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.