FDAFDA · Food and drugs·Recall number Z-2487-2019
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Published September 18, 2019 · Recall initiated: July 23, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Prolonged clotting times
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumentation Laboratory Co.
- Distributor
- States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.
- Lot
- Lot # : 42255701
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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