Device product
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Z-1379-2015
Product summary
- Firm
- TEM Systems Inc
- Event
- Event 70690
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 1574 x 5 vials per box
- Official record key
device-enforcement:Z-1379-2015
Official wording
Reason: Some of vials were found to be partially filled.
Code information: Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Some of vials were found to be partially filled.