Events

Recall of Device Recall Johnson & Johnson BANDAID Brand First Aid Products SECUREFLEX Wrap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Johnson & Johnson Consumer, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79454
  • Event Risk Class
    Class 2
  • Event Number
    Z-1203-2018
  • Event Initiated Date
    2017-12-18
  • Event Date Posted
    2018-03-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162351
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wrap, sterilization - Product Code FRG
  • 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.
  • 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 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

Device

Device Recall Johnson & Johnson BANDAID Brand First Aid Products SECUREFLEX Wrap

Manufacturer

Johnson & Johnson Consumer, Inc.
  • Manufacturer Address
    Johnson & Johnson Consumer, Inc., 199 Grandview Rd, Skillman NJ 08558-1311
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA