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
- Recall Initiated
- November 1, 2017
- Terminated
- July 22, 2020
- Recall Number
- Z-0552-2018
- Quantity
- 996 units
- Firm Location
- Saint Paul, MN
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
Lot / Code Info
(a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2
Root Cause
Packaging process control
Action Taken
The firm initiated their recall on 11/01/2017 by letter. The letter requested the consignee cease distribution of the recalled product, isolate it pending return. Distributors were asked to notify their customers including a copy of the 3M recall notice.
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