Events

Recall of Device Recall 3M Coban SelfAdherent Wrap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company - Health Care Business.

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
    72780
  • Event Risk Class
    Class 2
  • Event Number
    Z-0601-2016
  • Event Initiated Date
    2015-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142249
  • 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
    Self-Adherent Wrap - Product Code FMP
  • Reason
    Product mislabeled as latex free. actual catalog number 1581, lot 2020-10an. contains latex. this could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.
  • Action
    Consignees were sent via certified mail on 12/1/2015 a 3M letter dated November 25, 2015 and an emal on 12/5/2015 for the updated 3M "Urgent Medical Device" letter dated November 25, 2015. The letter was addressed to 3M Health Care Distributor. The letter described the problem, device involved in the recall and the action required. Advised consignees to quarantine the product, notify their customers and to complete and return the "Product Recall Form". Distributors were also provided with a "Customer" letter for distribution. For questions contact 3M Customer Helpline 1-800-228-3957.

Device

Device Recall 3M Coban SelfAdherent Wrap
  • Model / Serial
    Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US nationwide distribution.
  • Product Description
    3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Manufacturer Address
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA