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Terminated

COACH Self-Adhering Sports Wrap (size: 3in)

FDA Recall Z-1202-2018 · Posted 2018-03-27

Recall StatusTerminated
Product CodeFQM
Date Initiated2017-12-18
Date Terminated2020-04-14

Reason for Recall

Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.

Firm Action

On December 18, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to retailers and warehouses with intentions to notify all affected individuals, including customers of the recall. The recall letter requests that the following actions be taken: 1. Immediately examine your inventory and quarantine the above-mentioned product subject to recall. In addition, if you may have further distributed this product to retailers, warehouses or distributors, please identify and send a list of these locations to Stericycle at [email protected] and they will be notified. 2. Please complete the enclosed Business Reply Form and return immediately by emailing to [email protected] or faxing to (1-888-965-5802). 3. If you have any questions regarding the form, please call Stericycle at (1-855-215-5023). Please return ALL inventory of the identified product above. No product other than that specified is to be returned. Questions or concerns can be directed to 1-855-215-5023

Root Cause

Labeling design

Distribution Pattern

Nationally

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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