Date Initiated by Firm |
October 02, 2018 |
Create Date |
December 05, 2018 |
Recall Status1 |
Terminated 3 on August 28, 2023 |
Recall Number |
Z-0556-2019 |
Recall Event ID |
81178 |
Product Classification |
Pack, hot or cold, disposable - Product Code IMD
|
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.
|
Code Information |
a) UPC 0573301311 Bundled Lot Number 8054HA Carton/Pouch Number T26686 b) UPC 0573301311 Bundled Lot Number 8054HB Carton/Pouch Number T26686 |
Recalling Firm/ Manufacturer |
Pfizer Inc. 235 E 42nd St New York NY 10017-5703
|
For Additional Information Contact |
Jessica Smith 212-733-6213
|
Manufacturer Reason for Recall |
The firm received complaints of the wrap coming apart and leaking granular material
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FDA Determined Cause 2 |
Device Design |
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. |
Quantity in Commerce |
4956 units |
Distribution |
US Nationwide Distribution and PR |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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