FDA Device recall Z-2487-2019
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
- FDA Device
- Class II
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of ROTEM ex-tem Rest of the world part No: 503-05 (ROW) by Instrumentation Laboratory, citing prolonged clotting times.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2487-2019 |
| 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 Rest of the world part No: 503-05 (ROW)
Reason
Prolonged clotting times
Identifiers
| code_info | Lot # : 42255701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2487-2019%22
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