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U.S. Department of Health and Human Services

Class 2 Device Recall THERA PEARL 3in1 BREAST THERAPY

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  Class 2 Device Recall THERA PEARL 3in1 BREAST THERAPY see related information
Date Initiated by Firm August 14, 2012
Date Posted February 04, 2013
Recall Status1 Terminated 3 on March 08, 2013
Recall Number Z-0784-2013
Recall Event ID 63390
Product Classification Pack, hot or cold, reuseable - Product Code IME
Product THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box.

The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
Code Information Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01
Recalling Firm/
Manufacturer		 Lansinoh Laboratories Inc
333 N Fairfax St Ste 400
Alexandria VA 22314-2632
For Additional Information Contact Richard Thome
703-299-6477
Manufacturer Reason
for Recall		 The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
FDA Determined
Cause 2		 Error in labeling
Action Lansinoh Laboratories, Inc. sent an Urgent Product Recall letter dated August 14, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distributing and quarantine the affected product. Customers were informed that a credit would be issued for the affected product and they were asked to mail the postage paid Business Reply Card even if they do not have the affected product. If necessary call 1-877-366-1182 to arrange pickup. For questions customers were instructed to call the Customer Service Center at 1-800-292-4794. For questions regarding this recall call 703-299-6477.
Quantity in Commerce 51,472 units
Distribution Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
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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