FDA Device recall Z-0631-2017
Fluid Management Set
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of Fluid Management Set by Merit Medical Systems, citing merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0631-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-23 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Fluid Management Set. Catalog Number K08-MP5159A
Reason
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Identifiers
| code_info | Lot Number: H996433 |
|---|
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-0631-2017%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.