FDA Device recall Z-2485-2019
ROTEM ex-tem
- FDA Device
- Class II
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of ROTEM ex-tem by Instrumentation Laboratory, citing prolonged clotting times.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2485-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-23 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Instrumentation Laboratory |
| Distribution | IL, MI, WI |
Product
ROTEM ex-tem; US Part No: 503-05-US
Reason
Prolonged clotting times
Identifiers
| code_info | Lot # 42255901 (United States) |
|---|
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-2485-2019%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.