Recall Z-1674-2012
Water Pik, Inc. · initiated April 3, 2012
Product
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.
Codes / lots: All lots and codes manufactured between May 2010 and July 2011.
Reason for recall
Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.
FDA-determined cause: Device Design
Action taken
Water Pik has generated a Press Release letter dated May 2012. The letter included safety information and instructions for the consumer to contact Waterpik for a replacement model if they experience water intrusion into the battery compartment of their device. For additional information go to www.waterpiksinusense.com/exchange.
Details
- Recall number
- Z-1674-2012
- Initiated
- April 3, 2012
- Posted by FDA
- May 25, 2012
- Terminated
- August 7, 2012
- Product code
- KMA – Irrigator, Powered Nasal
- Quantity
- 105257 individual units
- Distribution
- US Nationwide Distribution.
- Recalling firm
- Water Pik, Inc., Fort Collins, CO