Recall Z-0790-03 ยท KFZ Humidifier, Non-Direct Patient Interface (Home-Use)
KAZ Inc.
Vicks 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.
| Date | May 8, 2003 (initiated Apr 15, 2003) |
| Status | Terminated |
| Reason | Humidifiers may overheat. |
| Root cause | Other |
| Action | Letters 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 | 110,000 units |
| Distribution | The 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.