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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 Recall
THERA PEARL 3in1 BREAST THERAPY
see related information
Date Posted February 04, 2013
Recall Status1 Terminated 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, Virginia 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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