What you need to know about BUTLER ClearDip recall
- What action was taken by Sunstar Americas, Inc. (SAI) and why?
Sunstar Americas, Inc. is voluntarily recalling 7 lots of BUTLER® Clear Dip®, a dental practice product in limited distribution. Routine quality testing indicates BUTLER® Clear Dip® products manufactured between July 30, 2020 and September 18, 2020 may be contaminated with the micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
- Has Sunstar received any reports of adverse events?
No. To date, there have been no reported complaints or adverse events associated with this defect.
- Who is at risk?
The bacteria related to this action rarely cause infection in healthy individuals but pose a higher risk to immunocompromised patients and patients with underlying Cystic Fibrosis and Chronic Granulomatous Disease. In these patients, there is potential for serious respiratory infection and adverse health consequences.
- Are other products affected?
No; no other Sunstar products are affected by this action.
- When was the voluntary recall initiated?
The voluntary recall was initiated on 23rd of March 2021 in the U.S.A., and 8th of April 2021 in the following countries: Japan, Hong Kong, Malaysia, Mexico, Thailand, and Taiwan.
- Where was the product distributed?
The product was distributed in the following countries: Japan, Hong Kong, Malaysia, Mexico, Thailand, Taiwan, U.S.A.
- What are the product’s ingredients?
The product is formulated with water and a surfactant and preserved with benzalkonium chloride and potassium sorbate.
- What is the product’s use?
BUTLER® Clear Dip® is a liquid product designed to prevent fogging and image distortion on mouth mirrors used in dental practice.
- How can the product be identified?
BUTLER® Clear Dip®’s opaque bottle (white with blue type) contains blue tinted liquid with a mild mint scent. The product is distributed in cases of 12 bottles per case, and single bottle. There is no labeled shelf life for the product. Affected product can be identified by the lot number.
- Which SKUs/lots are affected and how can the product be identified?
A total of seven lots of BUTLER® Clear Dip®, 16 fl. oz. (SKU 716PA) is affected by this voluntary recall action. The lots in scope of the recall were manufactured between July 30, 2020 and September 18, 2020 and are as follows:
UPC: 1 00 70942 75150 3
- How should I proceed if I have the affected product?
SAI is notifying parties to which it shipped directly affected products to do the following:Please examine your inventory to determine if you have any of the affected product lots. Immediately cease use of the product and quarantine (or isolate) to prevent further use.Please email email@example.com and your local Sunstar representative (find the list of local contacts at the bottom of this page) 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 (account number).
- If I’ve already used the product, can I continue to use it?
No. This product is the subject of a recall and so use should be stopped immediately.
- Who can I contact with concerns or questions?
For further information about this recall, please contact your local Sunstar representative.
Takashi Hayashi (Section Manager, Sales Planning Professional Channel Sales)
Tel. +66 (0) 86 408 6722
Tetsuya Hidaka (International Sales)
Tel. +81 80 2441 5690