FDA recall Z-0555-2019

Pfizer Inc. · Class II · device

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.

Reason for recall

The firm received complaints of the wrap coming apart and leaking granular material

Distribution

US Nationwide Distribution and PR

Key facts

Status
Terminated
Initiation date
2018-10-02
Report date
2018-12-12
Termination date
2023-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0555-2019