Recall Z-0784-2013 ยท IME Pack, Hot Or Cold, Reusable
Lansinoh Laboratories Inc
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.
| Date | Feb 4, 2013 (initiated Aug 14, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 51,472 units |
| Distribution | Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.