Z-2486-2019 Class II Terminated
FDA device recall Z-2486-2019 was initiated by Instrumentation Laboratory Co. on July 23, 2019 and is designated Class II. Reason for recall: Prolonged clotting times The recall status is terminated (terminated April 27, 2020). Affected quantity: 44 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2019
- Initiation Date
- July 23, 2019
- Termination Date
- April 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 kits
Product Description
ROTEM ex-tem Canada Part No: 503-05-CA
Reason for Recall
Prolonged clotting times
Distribution Pattern
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.
Code Information
Lot # : 42255801 (Canada)