FDA-Device2015-04-15Class II
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
TEM Systems Inc
Hazard
Some of vials were found to be partially filled.
Sold states
Nationwide Distribution
Affected count
Total 1574 x 5 vials per box
Manufactured in
4309 Emperor Blvd Ste 100, N/A, Durham, NC, United States
Products
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1379-2015Don't want to check this manually?
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