FDA-Device2018-03-21Class II
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
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
158,179 units
Manufactured in
3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul, MN, United States
Products
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2018Don't want to check this manually?
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