Z-0555-2019 Class II Terminated
FDA device recall Z-0555-2019 was initiated by Pfizer Inc. on Oct 2, 2018 and is designated Class II. Reason for recall: The firm received complaints of the wrap coming apart and leaking granular material The recall status is terminated (terminated Aug 28, 2023). Affected quantity: 293880 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2018
- Initiation Date
- Oct 2, 2018
- Termination Date
- Aug 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 293880 units
Product Description
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.
Reason for Recall
The firm received complaints of the wrap coming apart and leaking granular material
Distribution Pattern
US Nationwide Distribution and PR
Code Information
a) UPC 0573302002 Carton/Pouch Number T26691 b) UPC 0573302044 Carton/Pouch Number T26693
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0555-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026