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U.S. Department of Health and Human Services

Class 2 Device Recall Thermacare HeatWraps Menstrual

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  Class 2 Device Recall Thermacare HeatWraps Menstrual see related information
Date Initiated by Firm October 02, 2018
Create Date December 05, 2018
Recall Status1 Open3, Classified
Recall Number Z-0555-2019
Recall Event ID 81178
Product Classification Pack, hot or cold, disposable - Product Code IMD
Product 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.
Code Information a) UPC 0573302002 Carton/Pouch Number T26691 b) UPC 0573302044  Carton/Pouch Number T26693
Recalling Firm/
Pfizer Inc.
235 E 42nd St
New York NY 10017-5703
For Additional Information Contact Jessica Smith
Manufacturer Reason
for Recall
The firm received complaints of the wrap coming apart and leaking granular material
FDA Determined
Cause 2
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 a press release on 11/26/2018.
Quantity in Commerce 293880 units
Distribution US Nationwide Distribution and PR
Total Product Life Cycle TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.