Z-0552-2018 Class II Terminated
FDA device recall Z-0552-2018 was initiated by 3M Company - Health Care Business on November 1, 2017 and is designated Class II. Reason for recall: Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus. The recall status is terminated (terminated July 22, 2020). Affected quantity: 996 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- November 1, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 996 units
Product Description
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 Pattern
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
Code Information
(a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2