Reported Apr 15, 2015 · Terminated
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
TEM Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TEM Systems Inc · 4309 Emperor Blvd Ste 100 · Durham, NC · 27703-8069
Is this the product you have?
- ROTROL P Control for ROTEM delta Thromboelastometry System
- Manufactured forTem Innovations GmbH
- Lot codes and dates
Article number 503-25 (US ROTROL P)Lot no. 41819801exp date 2016-11 and Lot no. 41855701exp date 2017-06
- Amount recalled
- Total 1574 x 5 vials per box
Where it was sold
- Nationwide
Why it was recalled
Some of vials were found to be partially filled.
This product could cause temporary or reversible health problems — stop using it.
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