FDA Recall Terminated

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.

Recall: Z-0556-2019 · Initiated October 2, 2018

Recall

Recall Number
Z-0556-2019
Event Number
81178
Firm
Pfizer Inc.
FEI Number
2416101
Product Code
IMD
Status
Terminated
Root Cause
Device Design
Initiated
October 2, 2018
Terminated
August 28, 2023
Address
235 E 42nd St, New York, NY, 10017-5703

Description

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.

Reason

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

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.

Distribution

US Nationwide Distribution and PR

Quantity

4956 units