ROTEM ex-tem Canada recall
ROTEM ex-tem Canada Part No: 503-05-CA
Why was ROTEM ex-tem Canada recalled?
Prolonged clotting times
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # : 42255801 (Canada)
- Product
- ROTEM ex-tem Canada Part No: 503-05-CA
- Recalling firm
- Instrumentation Laboratory Co.
- Quantity
- 44 kits
- Distribution
- 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.
- Recall date
- September 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)