Events

Recall of Device Recall Quest Myocardial Protection System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quest 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
    26429
  • Event Risk Class
    Class 2
  • Event Number
    Z-1037-03
  • Event Initiated Date
    2003-05-23
  • Event Date Posted
    2003-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27665
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Reason
    Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
  • Action
    The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.

Device

Device Recall Quest Myocardial Protection System
  • Model / Serial
    Catalog Number: 5001102 Lot numbers; 20823.R10; 20853.S01; and 20863.S04  Catalog Number 5001104, lot number 20706.S09  Lots manufactured but not distributed: Catalog Number 6001101, lot 20639.R10  Catalog Number 7001102, lot 20638.R10
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, PA, FL, ME, TX, MA, OH, ON, NM, WA, MO, GA, SC, MS, IL, LA, NC, NJ, MA, AK, TN, MT, WI, IN, WV, NE, Japan, Canada
  • Product Description
    Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
  • Manufacturer
    Quest Medical, Inc

Manufacturer

Quest Medical, Inc
  • Manufacturer Address
    Quest Medical, Inc, One Allentown Pkwy, Allen TX 75002
  • Source
    USFDA