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

FDA Recall #Z-1201-2018 — Class II — December 18, 2017

Recall #Z-1201-2018 Date: December 18, 2017 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

Johnson & Johnson Consumer, Inc. — Skillman, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Distribution

Nationally

Code Information

100497502 381370079286 3813700497530024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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