TEM Systems Inc recalls ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
- Recall date
- October 23, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1379-2015
- FDA classification
- Class II
- Brand / firm
- TEM Systems Inc
- Sold / distributed
- Nationwide Distribution
Why it was recalled
Some of vials were found to be partially filled.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
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