Recall Z-1206-2018 ยท FQM Bandage, Elastic
Johnson & Johnson Consumer, Inc.
Johnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 2in)
| Date | Mar 27, 2018 (initiated Dec 18, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | On 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 e |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.