FDA Device recall Z-1379-2015
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH
- FDA Device
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH by Tem Systems, citing some of vials were found to be partially filled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1379-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-23 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tem Systems |
| Distribution | US |
Product
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Reason
Some of vials were found to be partially filled.
Identifiers
| code_info | Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1379-2015%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.