FDA-Device2018-03-21Class II
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
3M Company - Health Care Business
Hazard
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.
Sold states
US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
Affected count
162,348 units
Manufactured in
3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul, MN, United States
Products
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2018Don't want to check this manually?
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