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U.S. Department of Health and Human Services

Class 2 Device Recall Waterpik

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  Class 2 Device Recall Waterpik see related information
Date Initiated by Firm April 03, 2012
Date Posted May 25, 2012
Recall Status1 Terminated 3 on August 07, 2012
Recall Number Z-1674-2012
Recall Event ID 61532
Product Classification Irrigator, powered nasal - Product Code KMA
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.
Code Information All lots and codes manufactured between May 2010 and July 2011.
Recalling Firm/
Manufacturer		 Water Pik, Inc.
1730 East Prospect Road
Fort Collins CO 80553-0001
For Additional Information Contact
970-221-8287
Manufacturer 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 2		 Device Design
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.
Quantity in Commerce 105257 individual units
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC 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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