Events

Recall of MPS Delivery Set

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
    72524
  • Event Risk Class
    Class 2
  • Event Number
    Z-0361-2016
  • Event Initiated Date
    2015-10-28
  • Event Date Posted
    2015-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141378
  • 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
    Heat-exchanger, cardiopulmonary bypass - Product Code DTR
  • Reason
    The products have been found to intermittently exhibit a seal failure during use.
  • Action
    The recalling firm issued a press release on 10/28/2015. The press release was posted on FDA website on 10/29/2015. The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15.

Device

MPS Delivery Set
  • Model / Serial
    0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08, 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04,  0493675U04, 0493685U07, 494465U07, 0494475U09, 0494855G01, 0495215U11, 0495225U11, 0495505G02, 495515G02, 0496535G08, 0496875G08, 496885G08, 0497245S02, 0495205U11, 497255S04, 0497655S04, 0498535S06, 0498545S06, 0492205E03, 0493695U04, 0494485U07, 0495525G02, 0497265S02, 0495965G04, 0492765E07
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
  • Product Description
    Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
  • Manufacturer
    Quest Medical, Inc.

Manufacturer

Quest Medical, Inc.
  • Manufacturer Address
    Quest Medical, Inc., 1 Allentown Pkwy, Allen TX 75002-4206
  • Manufacturer Parent Company (2017)
    Quest Medical Inc.
  • Source
    USFDA