Rotem Delta (2018-05-12)
ROTEM delta Recall Summary ROTEM delta medical devices used for blood coagulation testing have been recalled across Canada due to a classification issue. The recall affects healthcare facilities and laboratories that use this device. The manufacturer identified the need to reclassify the device, prompting this Class I recall.
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2019-03-15
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e15f0124-4483-4dbb-9748-e9c041d874aa