Z-1382-2021 Class II Terminated
FDA device recall Z-1382-2021 was initiated by Sunstar Americas, Inc. on March 23, 2021 and is designated Class II. Reason for recall: Product may be contaminated with Burkholderia contaminans. The recall status is terminated (terminated August 28, 2023). Affected quantity: 19471 bottles.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 23, 2021
- Termination Date
- August 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19471 bottles
Product Description
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Reason for Recall
Product may be contaminated with Burkholderia contaminans.
Distribution Pattern
US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico
Code Information
Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039