Device 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
Z-0552-2018
Product summary
- Event
- Event 78444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 996 units
- Official record key
device-enforcement:Z-0552-2018
Official wording
Reason: Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
Code information: (a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2
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
Derived failure modes
-
Microbial contamination
Mold was found