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U.S. Department of Health and Human Services

Class 2 Device Recall BUTLER Clear Dip

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 Class 2 Device Recall BUTLER Clear Dipsee related information
Date Initiated by FirmJanuary 14, 2022
Create DateMarch 03, 2022
Recall Status1 Terminated 3 on August 28, 2023
Recall NumberZ-0720-2022
Recall Event ID 89460
Product Classification Anti fog solution and accessories, endoscopy - Product Code OCT
ProductBUTLER Clear Dip, 12 bottles/case
Code Information SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD
FEI Number 1413787
Recalling Firm/
Manufacturer		 Sunstar Americas, Inc.
301 E Central Rd
Schaumburg IL 60195-1901
For Additional Information ContactCynthia Culmo
847-794-4241
Manufacturer Reason
for Recall		Product lacks premarket clearance.
FDA Determined
Cause 2		No Marketing Application
ActionA Recall Letter is being sent to all direct consignees who have received impacted product via USPS First Class mail The Recall Letter will be posted to the corporate web site at www.gumbrand.com Customers are instructed as follows: 1. Please examine your inventory to determine if you have any of the affected product lots 2. Please call 1-800-528-8537 or email: us.pcr@us.sunstar.com with the results of your inventory check (even if the affected lots are no longer in inventory), and if affected lots are present, provide the lot numbers, quantities, and a recall contact. 3. Complete the enclosed Return Response Form and mail, FAX or email the completed form as per the instructions provided. 4. The recalling firm will issue a call tag via UPS for any affected inventory to be returned 5. Upon receipt of the call tag return any affected products to the recalling firm 6. Because this recall is being initiated to the dental office level, the recalling firm asks that consignees also notify any parties to which you have further distributed the product.
Quantity in Commerce22514 ea
DistributionUnited States Nationwide distribution.
Total Product Life CycleTPLC Device Report
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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