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U.S. Department of Health and Human Services

Class 2 Device Recall Johnson & Johnson BANDAID Brand First Aid Products HURTFREE Wrap

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 Class 2 Device Recall Johnson & Johnson BANDAID Brand First Aid Products HURTFREE Wrapsee related information
Date Initiated by FirmDecember 18, 2017
Date PostedMarch 27, 2018
Recall Status1 Terminated 3 on April 14, 2020
Recall NumberZ-1205-2018
Recall Event ID 79454
Product Classification Bandage, elastic - Product Code FQM
ProductJohnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 1in)
Code Information 111614500 381371161454 10381371161451
Recalling Firm/
Manufacturer		 Johnson & Johnson Consumer, Inc.
199 Grandview Rd
Skillman NJ 08558-1311
For Additional Information ContactStericycle
908-904-2205
Manufacturer 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.
FDA Determined
Cause 2		Labeling design
ActionOn 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
DistributionNationally
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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