Recall Z-1379-2015— TEM Systems Inc
Class II · Terminated
Class II FDA medical device recall by TEM Systems Inc, initiated 2014-10-23, terminated 2015-08-13. It names 2 FDA 510(k) clearances: K101533, K083842. Product: ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.. Reason: Some of vials were found to be partially filled..
- Recalling firm
- TEM Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-23
- Terminated
- 2015-08-13
- Firm location
- Durham, NC, United States
510(k) clearances named in this recall
2 on FDA's record- K101533 — EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
- K083842 — ROTEM DELTA THROMBOELASTOMETRY SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Reason for recall
Some of vials were found to be partially filled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.