Z-1939-2020 Class II Terminated
FDA device recall Z-1939-2020 was initiated by Remel Inc. on January 4, 2019 and is designated Class II. Reason for recall: Potential for out of range microbial results The recall status is terminated (terminated August 17, 2020). Affected quantity: 250.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- January 4, 2019
- Termination Date
- August 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250
Product Description
SWIN 2017 database, Model YSW4000
Reason for Recall
Potential for out of range microbial results
Distribution Pattern
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Code Information
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