Events

Recall of Device Recall Proxima Set Up Pack III

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries, 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
    35123
  • Event Risk Class
    Class 2
  • Event Number
    Z-0777-06
  • Event Initiated Date
    2006-03-30
  • Event Date Posted
    2006-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45369
  • 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
    General Surgery Tray - Product Code LRO
  • Reason
    The product may not be sterile. the pouches were damaged during sterilization.
  • Action
    The direct account hospital was visited by a Medline sales representative on 3/30/06, and the affected product was retrieved and returned to Medline.

Device

Device Recall Proxima Set Up Pack III
  • Model / Serial
    Reorder number DYNJP1047, lot 5149116
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Texas
  • Product Description
    Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China
  • Manufacturer
    Medline Industries, Inc.

Manufacturer

Medline Industries, Inc.
  • Manufacturer Address
    Medline Industries, Inc., 1170 S Northpoint Blvd, Waukegan IL 60085-6757
  • Source
    USFDA