FDA recall Z-1202-2018

Johnson & Johnson Consumer, Inc. · Class II · device

Product

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

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.

Distribution

Nationally

Key facts

Status
Terminated
Initiation date
2017-12-18
Report date
2018-04-04
Termination date
2020-04-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Skillman, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2018