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U.S. Department of Health and Human Services

Class 2 Device Recall Vicks

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 Class 2 Device Recall Vickssee related information
Date Initiated by FirmApril 15, 2003
Date PostedMay 08, 2003
Recall Status1 Terminated 3 on February 24, 2005
Recall NumberZ-0790-03
Recall Event ID 26000
Product Classification Humidifier, Non-Direct Patient Interface (Home-Use) - Product Code KFZ
ProductVicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license from the Procter & Gamble Company, Cincinnati, OH 45202. UPC code 3 28785 20610 4.
Code Information 8-digit code ending in either 2KUO or 3KUO.
FEI Number 1314800
Recalling Firm/
Manufacturer		 KAZ Inc.
One Vapor Trail - 4411 Route 9
Hudson NY 12534
For Additional Information ContactRobert Girard
518-828-0450
Manufacturer Reason
for Recall		Humidifiers may overheat.
FDA Determined
Cause 2		Other
ActionLetters dated 4/16/2003 to direct accounts (wholesalers/retail distribution chains) with instructions to quarantine product, notify retail stores, and attempt to notify consumers who purchased the units. Posters will be posted at retail stores where the units were sold.
Quantity in Commerce110,000 units
DistributionThe product was distributed through 32 direct accounts (wholesalers and retail distribution chains) throughout the U.S. The firm estimates between 35,000 and 45,000 units remain in distribution channels; and between 65,000 and 75,000 are in homes.
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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