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.
FDA Recall Z-0555-2019 · Posted None
Advertisement
Recalling FirmPfizer Inc.
Recall StatusTerminated
Product CodeIMD
Date Initiated2018-10-02
Date Terminated2023-08-28
Product Quantity293880 units
Reason for Recall
The firm received complaints of the wrap coming apart and leaking granular material
Firm 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 a press release on 11/26/2018.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution and PR
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement