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Class 2 Device Recall THERA PEARL 3in1 BREAST THERAPY |
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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
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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
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For Additional Information Contact |
Richard Thome 703-299-6477
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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.
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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
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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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