FDA Device recall Z-1484-2017
AMS-636, 60" Microbore extension set
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of AMS-636, 60" Microbore extension set by Vygon Mfg Dba Churchill Medical Systems, citing incorrect priming volume printed on the device package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1484-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-20 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vygon Mfg Dba Churchill Medical Systems |
| Distribution | US |
Product
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Reason
Incorrect priming volume printed on the device package.
Identifiers
| code_info | 1610092D 1611091D 1612068D 1612074D |
|---|
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-1484-2017%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.