| | Class 2 Device Recall Butler Clear Dip |  |
| Date Initiated by Firm | March 23, 2021 |
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| Create Date | April 09, 2021 |
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| Recall Status1 |
Terminated 3 on August 28, 2023 |
| Recall Number | Z-1382-2021 |
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| Recall Event ID |
87600 |
| Product Classification |
Mirror, mouth - Product Code EAX
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| Product | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA |
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| Code Information |
Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039 |
| FEI Number |
1413787
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Recalling Firm/
Manufacturer |
Sunstar Americas, Inc.
301 E Central Rd
Schaumburg IL 60195-1901
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| For Additional Information Contact | Cynthia Culmo
847-794-4241 |
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Manufacturer Reason
for Recall | Product may be contaminated with Burkholderia contaminans. |
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FDA Determined
Cause 2 | Process control |
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| Action | Sunstar initiated the recall by letter and email on 03/23/2021. The letter requested the consignee check their inventory and isolate affected product, then contact customer service with the results. The firm requested the return of the product. Distributors are asked to notify their customers down to the user level. |
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| Quantity in Commerce | 19471 bottles |
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| Distribution | US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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