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U.S. Department of Health and Human Services

Class 2 Device Recall Crest SpinBrush ProWhitening

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 Class 2 Device Recall Crest SpinBrush ProWhiteningsee related information
Date Initiated by FirmFebruary 23, 2005
Date PostedMarch 11, 2005
Recall Status1 Terminated 3 on April 13, 2006
Recall NumberZ-0592-05
Recall Event ID 31259
Product Classification Toothbrush, Powered - Product Code JEQ
ProductThe product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening Medium Refill Heads, UPC776687800194.
Code Information All codes.
Recalling Firm/
Manufacturer
Proctor & Gamble Co
2 Procter And Gamble Plz
Cincinnati OH 45202-3315
For Additional Information ContactJohn G. Waldmann
513-622-1191
Manufacturer Reason
for Recall
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
FDA Determined
Cause 2
Other
ActionThe recalling firm sent a recall letter dated 2/23/05 and dated 3/4/05.
Quantity in Commerce15 million toothbrushes and refill heads
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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