TEM Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-1379-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

Product Classification:

Class II

Date Initiated: October 23, 2014

Date Posted: April 15, 2015

Recall Number: Z-1379-2015

Event ID: 70690

Reason for Recall:

Some of vials were found to be partially filled.

Status: Terminated

Product Quantity: Total 1574 x 5 vials per box

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

Voluntary or Mandated:

Voluntary: Firm initiated