TEM Systems Inc recalls ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

Recalled April 15, 2015 · FDA recall Z-1379-2015 · TEM Systems

Hazard

Some of vials were found to be partially filled. · FDA Class II

Units

Total 1574 x 5 vials per box

Sold at

Nationwide Distribution

Description

Some of vials were found to be partially filled.

Product

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

Manufacturer(s)

TEM Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →