Events

Recall of Device Recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm c 40cm)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Progressive Medical 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
    63445
  • Event Risk Class
    Class 2
  • Event Number
    Z-0276-2013
  • Event Initiated Date
    2011-12-09
  • Event Date Posted
    2012-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113796
  • 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
    Dissector surgical General & Plastic Surgery - Product Code GDI
  • Reason
    Some of the sterile packages had broken seals.
  • Action
    Progressive Medical Inc contacted their customers via telephone on December 9, 2011, through December 15, 2011. Customers were informed the reason for recall was explained and the customer was asked if any of the lot remained in their inventory. If inventory remained, the recalling firm sent them a return goods authorization number and informed them the product would be replaced. For further questions please call (314) 961-5786.

Device

Device Recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm c 40cm)
  • Model / Serial
    Lot 1108-01
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
  • Product Description
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. || The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
  • Manufacturer
    Progressive Medical Inc

Manufacturer

Progressive Medical Inc
  • Manufacturer Address
    Progressive Medical Inc, 11085 Gravois Industrial Ct, Saint Louis MO 63128-2012
  • Manufacturer Parent Company (2017)
    Progressive Medical Inc
  • Source
    USFDA