Are Thermacare Menstrual Wraps Fda Registered

Class 2 Device Recall ThermaCare HEATWRAPS

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Class 2 Device Recall ThermaCare HEATWRAPS Engagement Initiated past Firm April 26, 2019 Create Appointment May 28, 2019 Recall Statusi Openthree, Classified Remember Number Z-1496-2019 Recall Event ID 82781 Production Classification Pack, hot or cold, disposable - Product Code IMD Product ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and articulation pains associated with overexertion, strains, sprains, and arthritis and menstrual hurting. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft atomic number 26, carbon or absorbent gelling textile and alkali solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat. Code Information Lot Numbers:  a) S23902 b) W37940 c) S00639 Recalling Firm/ Manufacturer PF Consumer Healthcare 1 LLC 1231 Wyandotte Dr Albany GA 31705-3815 For Boosted Information Contact Kim Bencker 610-329-1340 Manufacturer Reason for Recall There is the potential that a HeatWrap could include cells that have a higher jail cell temperature than specified in lot S97473. The employ of rut cell wrap with increased temperatures poses a potential take chances of pare injuries such as burns/blisters and/or skin irritation on the wrap-practical area. FDA Determined Cause 2 Other Action The business firm initiated the call up by press release on 04/26/2019. Notification packages to direct consignees were sent on 04/29/2019. The consignees were directed to cease distribution and render the product. Distributors were directed to sub-call back. Retailers were asked to post the printing release either at the greenbacks register or another prominent location. Quantity in Commerce 225617 individual estrus wraps Distribution Worldwide distribution - Usa Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland. Total Product Life Cycle TPLC Device Report 1 A tape 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 activity as a think, and it is updated for a final fourth dimension when the recall is terminated. Learn more virtually medical device recalls. 2 Per FDA policy, recall cause determinations are discipline to modification upwards to the signal of termination of the recall. 3 The manufacturer has initiated the recall and not all products accept been corrected or removed. This record volition be updated equally the status changes.

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Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=172945

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