Events

Recall of ASEPT Pleural Drainage System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pfm 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
    69666
  • Event Risk Class
    Class 2
  • Event Number
    Z-0561-2015
  • Event Initiated Date
    2014-10-20
  • Event Date Posted
    2014-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131294
  • 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
    Apparatus, suction, patient care - Product Code DWM
  • Reason
    Pfm medical is recalling catheters and other medical devices because they may exceed usp limits for bacterial endotoxin.
  • Action
    PFm Medical sent an Urgent Device Recall Notification letter dated November 3, 2014 to all their customers who purchased the catheters and other medical devices. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the recall acknowledgement/reply form and fax it to (760) 758-1167 or email it to customerservice@pfmmedicalusa.com. Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749.

Device

ASEPT Pleural Drainage System
  • Model / Serial
    Lot No. 1307-024, 1302-031, 1210-015
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
  • Product Description
    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 || Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
  • Manufacturer
    Pfm Medical Inc

Manufacturer

Pfm Medical Inc
  • Manufacturer Address
    Pfm Medical Inc, 1815 Aston Ave Ste 106, Carlsbad CA 92008-7340
  • Manufacturer Parent Company (2017)
    Pfm Medical Incorporated
  • Source
    USFDA