Summary
The FDA issued a Class II for BUTLER Clear Dip, 12 bottles/case by Sunstar Americas, Inc.. Reason: Product lacks premarket clearance..
Details
Source
Device Recall
External ID
Z-0720-2022
Action Date
2022-03-09
Status
Terminated
Category
device
Product Description
BUTLER Clear Dip, 12 bottles/case
Lot/Code Info: SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD
Quantity Affected: 22514 ea
Reason for Recall
Product lacks premarket clearance.
Distribution
United States Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-14
Company
Schaumburg, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sunstar Americas, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sunstar Americas, Inc. have FDA actions?
This is the only FDA action we have on record for Sunstar Americas, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0720-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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