FDA Enforcement
Class II
Terminated
ROTEM ex-tem; US Part No: 503-05-US
Recall: Z-2485-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2485-2019
- Event ID
- 83523
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Instrumentation Laboratory Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 18, 2019
- Initiation Date
- July 23, 2019
- Classification Date
- September 6, 2019
- Termination Date
- April 27, 2020
- Address
- 180 Hartwell Rd, Bedford, MA, 01730-2443, United States
Description
ROTEM ex-tem; US Part No: 503-05-US
Reason
Prolonged clotting times
Code Info
Lot # 42255901 (United States)
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.
Quantity
364 kits