FDA-Device2018-02-14Class II
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
3M Company - Health Care Business
Hazard
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Sold states
AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV
Affected count
996 units
Manufactured in
3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, United States
Products
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2018Don't want to check this manually?
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