FDA-Device2019-09-18Class II
ROTEM ex-tem Canada Part No: 503-05-CA
Instrumentation Laboratory Co.
Hazard
Prolonged clotting times
Sold states
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.
Affected count
44 kits
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Products
ROTEM ex-tem Canada Part No: 503-05-CA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2486-2019Don't want to check this manually?
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