FDA Device recall Z-1385-2019
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions
- FDA Device
- Class I
- terminated
- Published 2019-07-03
On 2019-07-03 the FDA classified a Class I recall of enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions by Vyaire Medical, citing testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1385-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-03-13 |
| Published | 2019-07-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vyaire Medical |
| Distribution | US |
Product
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Reason
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Identifiers
| code_info | Part Number: 980200EU. All units distributed through March 7, 2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1385-2019%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.