FDA Recall Terminated

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.

Recall: Z-1674-2012 · Initiated April 3, 2012

Recall

Recall Number
Z-1674-2012
Event Number
61532
Firm
Water Pik, Inc.
FEI Number
1712259
Product Code
KMA
Status
Terminated
Root Cause
Device Design
Initiated
April 3, 2012
Posted
May 25, 2012
Terminated
August 7, 2012
Address
1730 East Prospect Road Fort, Collins, CO, 80553-0001

Description

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.

Reason

Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.

Action

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.

Distribution

US Nationwide Distribution.

Quantity

105257 individual units