FDA recall Z-0552-2018

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-11-01

Report date

2018-02-14

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2018