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Recall Observatory FDA recall evidence

Device product

Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.

Z-0554-2019

October 02, 2018

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 81178
Status
Terminated
Classification
Class II
Quantity
119232 units
Official record key
device-enforcement:Z-0554-2019

Official wording

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

Code information: a) UPC 0573301314 Carton/Pouch Lot Number S68516 b) UPC 0573301303 Carton/Pouch Lot Number T26686

Distribution pattern: US Nationwide Distribution and PR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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