CLASS II Device recall · Reported 26 Dec 2012 · FDA Enforcement Report

Medrad(R) Continuum MR Infusion System Primary VSA Stopcock recalled

Medrad is recalling Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System, distributed nationwide in the US. The recall was initiated on 18 Apr 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number - Primary VSA Stopcock Set: 3015156. See firm's website - www.medrad.com for specific serial and lot numbers.

Quantity recalled1,229 Pumps total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0599-2013
FDA event ID: 61734
Recalling firm: Medrad, Indianola, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Apr 2012
FDA classified: 20 Dec 2012
Reported: 26 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Apr 2012	Recall initiated by company
20 Dec 2012	Classified by FDA	+246 days
26 Dec 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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 procedure functioning while either stationary or mobile.

Where it was distributed

Worldwide distribution: USA (nationwide) and countries of: Australia, Bermuda, Brazil, Canada, China, Chile, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Guam, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Mexico, Malaysia, Netherland, Poland, Portugal, Puerto Rico, Sweden, Singapore, Taiwan, Thailand, and Venezula.

Nationwide Puerto Rico

Questions about this recall

Is Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System recalled?

Yes. Medrad recalled Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System on 18 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-0599-2013.

Why was it recalled?

Which lots are affected?

Catalog number - Primary VSA Stopcock Set: 3015156. See firm's website - www.medrad.com for specific serial and lot numbers.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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