FDA-Device2025-12-03Class IIMISBRANDING
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Hazard
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK.
Affected count
1,594
Manufactured in
5919 Sea Otter Pl Ste 200, N/A, Carlsbad, CA, United States
Products
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2026Want us to check the next one for you?
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