FDA (Devices) recall action 61734

Medrad Inc recalled 11 products on 2012-12-26

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2012-12-26
Critical: 0
Units: 13,519

Why these products were recalled

Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

HighFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow rate issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System 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
Category
Distribution
0 states
ModerateFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System 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 functio
Category
Distribution
0 states
ModerateFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System 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 f
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System 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 funct
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System 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 fun
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System 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
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System 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 f
Category
Distribution
0 states
ModerateFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System 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 p
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System 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 proc
Category
Distribution
0 states
ModerateFDA (Devices)··2012-12-26
Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets due to a variation that may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System 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 funct
Category
Distribution
0 states
HighFDA (Devices)··2012-12-26
Bayer Recalls Medrad Continuum MR Infusion Pump Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System 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 eit
Category
Distribution
0 states