Recall Z-0555-2019 ยท IMD Pack, Hot Or Cold, Disposable
Pfizer Inc.
Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
| Date | Oct 2, 2018 |
| Status | Terminated |
| Reason | The firm received complaints of the wrap coming apart and leaking granular material |
| Root cause | Device Design |
| Action | Pfizer, Inc. initiated the recall by letter on 10/02/2018 to the direct accounts. The notice instructed the direct consignees to conduct a sub-recall by notifying any of their accounts to determine if they had any of the affected lot(s) in their inventory at any of their locations. If so, the recalling firm requested that they discontinue distributing the product lot and promptly return the affected product to Pfizer Inc. (c/o Stericycle Inc.). The firm expanded the scope of their recall to the consumer level and disseminated a notice on 11/27/2018 to its direct accounts. The firm issued |
| Quantity | 293880 units |
| Distribution | US Nationwide Distribution and PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.