Events

Recall of Device Recall Bemis/ Medline

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bemis Health Care,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
    36160
  • Event Risk Class
    Class 2
  • Event Number
    Z-0170-2007
  • Event Initiated Date
    2006-08-23
  • Event Date Posted
    2006-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48102
  • 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
    sharps container - Product Code MMK
  • Reason
    The 5 quart wall safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.
  • Action
    Letters were mailed to consignees August 23, 2006 describing the product with lots and model numbers. Customers were asked to have product destroyed rather than returned to Bemis. Enclosed with the letter was a Recall Acknowledgement/Destroy in field form that they were instructed to fax to BEMIS. A second letter was sent out to the non-responders on September 13, 2005.

Device

Device Recall Bemis/ Medline
  • Model / Serial
    BEMIS: Model 7H150 020 includes lot 20060001 to 20060016;  BEMiS: Model 7H150 030 includes lot 20050006, 20060001 to 20060008;  BEMIS: Model 7H150 040 includes lot 20060001 to 20060008;  Medline Model 7H950 030 includes lot 20050027, 20060001 to 20060008.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI.
  • Manufacturer
    Bemis Health Care,Inc

Manufacturer

Bemis Health Care,Inc
  • Manufacturer Address
    Bemis Health Care,Inc, 300 Mill St, Sheboygan Falls WI 53085-1807
  • Source
    USFDA