FDA recall Z-0946-2018

3M Company - Health Care Business · Class II · device

Product

ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

Reason for recall

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2018-01-31
Report date: 2018-03-21
Termination date: 2021-02-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2018