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Recall Observatory FDA recall evidence

Device product

Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)

Z-1206-2018

December 18, 2017

Class II

Product summary

Firm
Johnson & Johnson Consumer, Inc.
Event
Event 79454
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1206-2018

Official wording

Reason: 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.

Code information: 111614600 381371161461 103813711614680000

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.