Device product
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Z-1382-2021
Product summary
- Event
- Event 87600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19471 bottles
- Official record key
device-enforcement:Z-1382-2021
Official wording
Reason: Product may be contaminated with Burkholderia contaminans.
Code information: Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039
Distribution pattern: US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico
Derived failure modes
-
Microbial contamination
contaminated with Burkholderia