ACE BRAND recalled over mold contamination

Recall date

November 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

3M Company - Health Care Business recalls ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection L…

Recall number

Z-0552-2018

FDA classification

Class II

Brand / firm

3M Company - Health Care Business

Sold / distributed

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

Why it was recalled

Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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