Recall Z-0622-2011 ยท IMD Pack, Hot Or Cold, Disposable
Pfizer Global
ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609
| Date | Dec 16, 2010 (initiated Sep 24, 2010) |
| Status | Terminated |
| Reason | The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns. |
| Root cause | Packaging process control |
| Action | Wyeth Consumer Healthcare issued an Urgent Voluntary Medical Device Recall letter dated September 24, 2010 to direct accounts, and issued a press release. The firm is removing the product in question from store shelves and asking consumers who have purchased the product to record the lot number, throw the product away in its entirety without opening the foil pouch and call 1 800 232-3383 for replacement. Direct accounts were instructed to remove the affected product from sale and return it immediately. If they further distributed the product they were instructed to notify their customers of th |
| Quantity | 192000 cartons (3 wraps per carton) |
| Distribution | Nationwide Distribution: Throughout the U.S. and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.