RecallDepth

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

Company
3M Company Health Care Business 3M Center
Recall Initiated
January 31, 2018
Terminated
February 11, 2021
Recall Number
Z-0946-2018
Quantity
162,348 units
Firm Location
Saint Paul, MN

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

Lot / Code Info

All lots

Root Cause

Error in labeling

Action Taken

The firm initiated their recall by letter on 01/30/2018. The letter stated the following: "Actions required: 1. Immediately discontinue sale of Futuro" Quick Strap Ankle Brace. 2. Isolate or quarantine any stock of the Futuro" Quick Strap Ankle Brace. 3. Call 1-866-746-2524, option #2, Monday to Friday, 8:00 am 4:30 pm Central time, to arrange for the return of the Futuro" Quick Strap Ankle Brace, Cat# 47736EN. 4. If you have further distributed the Futuro" Quick Strap Ankle Brace, please notify any of your customers at once. Please include a copy of this letter in your communications. We apologize for any inconvenience this may cause you. Should you have any questions regarding the product and return process, please feel free to contact 3M Customer Service at 1-866-746-2524, option 2, Monday to Friday, 8:00 am 4:30 pm Central Time."

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