Instrumentation Laboratory Co. recalls ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
- Recall date
- July 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2487-2019
- FDA classification
- Class II
- Brand / firm
- Instrumentation Laboratory Co.
- Sold / distributed
- 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, Sw…
Why it was recalled
Prolonged clotting times
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
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