Recall Z-0552-2018— 3M Company - Health Care Business
Class II · Terminated
Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2017-11-01, terminated 2020-07-22. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus..
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-01
- Terminated
- 2020-07-22
- Firm location
- Saint Paul, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.