Recall Z-1206-2018— Johnson & Johnson Consumer, Inc.
Class II · Terminated
Class II FDA medical device recall by Johnson & Johnson Consumer, Inc., initiated 2017-12-18, terminated 2020-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in). 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..
- Recalling firm
- Johnson & Johnson Consumer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-18
- Terminated
- 2020-04-14
- Firm location
- Skillman, NJ, United States
Product description
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.