FDA recall Z-1382-2021

Sunstar Americas, Inc. · Class II · device

Product

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

Reason for recall

Product may be contaminated with Burkholderia contaminans.

Distribution

US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico

Key facts

Status
Terminated
Initiation date
2021-03-23
Report date
2021-04-21
Termination date
2023-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1382-2021