FDA Enforcement
Class II
Terminated
SWIN 2017 database, Model YSW4000
Recall: Z-1939-2020
·
Reported May 20, 2020
Enforcement
- Recall Number
- Z-1939-2020
- Event ID
- 84764
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Remel Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- May 20, 2020
- Initiation Date
- January 4, 2019
- Classification Date
- May 8, 2020
- Termination Date
- August 17, 2020
- Address
- 1 Thermo Fisher Way, N/A, Oakwood Village, OH, 44146-6536, United States
Description
SWIN 2017 database, Model YSW4000
Reason
Potential for out of range microbial results
Code Info
...
Distribution
...
Quantity
250