Z-1379-2015 Class II Terminated
FDA device recall Z-1379-2015 was initiated by TEM Systems Inc on October 23, 2014 and is designated Class II. Reason for recall: Some of vials were found to be partially filled. The recall status is terminated (terminated August 13, 2015). Affected quantity: Total 1574 x 5 vials per box.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2015
- Initiation Date
- October 23, 2014
- Termination Date
- August 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 1574 x 5 vials per box
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.
Distribution Pattern
Nationwide Distribution
Code Information
Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.