Recall Z-1382-2021— Sunstar Americas, Inc.

Name: FDA recall Z-1382-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-23

Class II · Terminated

Class II FDA medical device recall by Sunstar Americas, Inc., initiated 2021-03-23, terminated 2023-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA. Reason: Product may be contaminated with Burkholderia contaminans..

Recalling firm: Sunstar Americas, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-23
Terminated: 2023-08-28
Firm location: Schaumburg, IL, United States

Product description

SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

Reason for recall

Product may be contaminated with Burkholderia contaminans.

Data sourced from openFDA. This site is unofficial and independent of the FDA.