Recall Z-1673-2014— Bayer Corp

Name: FDA recall Z-1673-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-03

Class II · Terminated

Class II FDA medical device recall by Bayer Corp, initiated 2014-04-03, terminated 2015-04-16. It names one FDA 510(k) clearance: K073051. Product: Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.. Reason: There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008..

Recalling firm: Bayer Corp
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Terminated: 2015-04-16
Firm location: Warrendale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K073051 — MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORYMedrad, Inc.·cleared 2008-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Reason for recall

There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.

Data sourced from openFDA. This site is unofficial and independent of the FDA.