Events

Recall of Device Recall 3M Micropore Surgical Tape

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
    54640
  • Event Risk Class
    Class 2
  • Event Number
    Z-1413-2010
  • Event Initiated Date
    2010-01-29
  • Event Date Posted
    2010-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88871
  • 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
    Surgical Tape - Product Code KGX
  • Reason
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • Action
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.

Device

Device Recall 3M Micropore Surgical Tape
  • Model / Serial
    Lot numbers containing "2014" and lot numbers beginning with "2015-01" followed by two-character letters: AA, AB, AC, AD, AE, AF, AH, AI, AL, AN, BW.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution, and Puerto Rico.
  • Product Description
    3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Manufacturer Address
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA