Z-0603-2013Class II

Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who...

Name: Z-0603-2013 Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who...
Creator: Medrad Inc
Published: 2012-04-18
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2012-04-18 / Terminated / root cause: manufacturing process

FDA source

Medrad Inc began a recall of Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR... on 2012-04-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0603-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-18
Posted: 2012-12-20
Terminated: 2015-08-17
Recalling firm: Medrad, Inc.
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 functioning while either stationary or mobile.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Bayer HealthCare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 17, 2012 via the USPS certified mail to its consignees/customers. The firm expanded the recall on May 11, 2012 and sent a second letter entitled "EXPANDED URGENT MEDICAL DEVICE RECALL" to its affected consignees/customers notifying them of the additional issue. The letters described the product, problem and actions to be taken. The customers were instructed to return pump now; contact customer support at 1-877-229-3767 for a return goods authorization (RGA); complete and return Response Form, include RGA numbers, via Fax to Bayer Compliance at 412-4060942, and/or wait to return the pump when they begin contacting customers with this subset of pumps in August to make arrangements for a replacement pump. If you have questions, please contact our customer support team at 1-877-229-3767 or visit www.medrad.com for more information.
Quantity in commerce: 1,229 Pumps total
Distribution: 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.
Product codes and lots: Catalog number - Secondary Spike Set: 3015160. See firm's website - www.medrad.com for specific serial and lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0603-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0595-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0596-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0597-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0598-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0599-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0600-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0601-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0602-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0603-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0604-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0605-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20

Product code FPA

K051499Class IIIntravascular Administration Set and Extension SetMedegen Medical Manufacturing Services / cleared 2005-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)