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
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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
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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 |
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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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