COACH Self-Adhering Sports Wrap (size: 2in)

FDA device recall Z-1201-2018 · posted 2018-03-27 · Terminated

Recall details

Recalling firm

Johnson & Johnson Consumer, Inc.

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.

Action taken

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 BandAid8687@stericycle.com and they will be notified. 2. Please complete the enclosed Business Reply Form and return immediately by emailing to BandAid8687@stericycle.com 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

Status

Terminated

Product code

FQM

Distribution

Nationally

Date initiated

2017-12-18

Date posted

2018-03-27

Date terminated

2020-04-14

Location

Skillman, NJ