Recall Z-0552-2018 ยท NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile
3M Company - Health Care Business
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
| Date | Nov 1, 2017 |
| Status | Terminated |
| Reason | Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 996 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.