Skip to content
Recall Observatory FDA recall evidence

Device product

Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.

Z-0556-2019

October 02, 2018

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 81178
Status
Terminated
Classification
Class II
Quantity
4956 units
Official record key
device-enforcement:Z-0556-2019

Official wording

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

Code information: a) UPC 0573301311 Bundled Lot Number 8054HA Carton/Pouch Number T26686 b) UPC 0573301311 Bundled Lot Number 8054HB Carton/Pouch 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