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Recall Observatory FDA recall evidence

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

November 01, 2017

Class II

Product summary

Firm
3M Company - Health Care Business
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

    reason.microbial_contamination · v1.0.0

    Mold was found