Device product

FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6

Z-0945-2018

January 31, 2018

Class II

Product summary

Firm: 3M Company - Health Care Business
Event: Event 79051
Status: Terminated
Classification: Class II
Quantity: 158,179 units
Official record key: device-enforcement:Z-0945-2018

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.