Events

Recall of Device Recall Bemis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bemis Manufacturing Co..

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
    28497
  • Event Risk Class
    Class 2
  • Event Number
    Z-0789-04
  • Event Initiated Date
    2004-02-25
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32000
  • 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
    Container, Sharps - Product Code MMK
  • Reason
    The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occluded with plastic.
  • Action
    Recall letters dated 2/25/04 requested the return of the product and providing for notification of the subaccounts that may have received the product.

Device

Device Recall Bemis
  • Model / Serial
    Lot #20040001 and Lot #20040004
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled containers were shipped to consignees in Connecticut, Florida, Georgia, Pennsylvania and Tennessee in the United States, and to a consignee in Canada.
  • Product Description
    Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only difference between the models is in color. Model 102 040 is yellow, Model 102 020 is beige and Model 102 030 is red. )
  • Manufacturer
    Bemis Manufacturing Co.

Manufacturer

Bemis Manufacturing Co.
  • Manufacturer Address
    Bemis Manufacturing Co., Highway Pp West, Sheboygan Falls WI 53085
  • Source
    USFDA