Events

Recall of Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LeMaitre Vascular, 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
    32971
  • Event Risk Class
    Class 2
  • Event Number
    Z-0219-06
  • Event Initiated Date
    2005-05-17
  • Event Date Posted
    2005-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41161
  • 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
    Occluder, Catheter Tip - Product Code DQT
  • Reason
    Lemaitre vascular is recalling certain lots of its pruitt aortic occlusion catheters due to a packaging defect which could compromise product sterility.
  • Action
    The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.

Device

Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled...
  • Model / Serial
    Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed in the United States, Canada, Japan and the European Union.
  • Product Description
    Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • Manufacturer Address
    LeMaitre Vascular, Inc., 3101 37th Ave N, St Petersburg FL 33713-1509
  • Source
    USFDA