Events

Recall of Device Recall Nexcare HoldFast Roll Gauze

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company / Medical Division.

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
    30407
  • Event Risk Class
    Class 2
  • Event Number
    Z-0264-05
  • Event Initiated Date
    2004-11-05
  • Event Date Posted
    2004-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35815
  • 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
    Dressing, Wound, Drug - Product Code FRO
  • Reason
    Mislabeled - nexcare holdfast roll gauze were not sterilized, the product is labeled with 'sterility guaranteed unless package is opened or damaged'.
  • Action
    3M sent letter dated 11/05/04 to distributors asking distributors to notify their customers immediately who received this lot number. A sample notification letter was also included to the distributors for instructing the retail location to return product to 3M.

Device

Device Recall Nexcare HoldFast Roll Gauze
  • Model / Serial
    Lot # 4267. Catalog number HF-2R
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Product sent to 38 retail healthcare product distributors located throughout the US and guam. States include MN, IL, MO, CO, TX, PA, MA, MD, NJ, NY, GA, NC, SC, WA, CA and Hawaii
  • Product Description
    3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no labeling.
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Manufacturer Address
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, South St Paul MN 55411
  • Source
    USFDA