Medrad Inc: Medical Device Recall in 2012 - (Recall #: Z-0605-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 functioning while either stationary or mobile.

Product Classification:

Class II

Date Initiated: April 18, 2012

Date Posted: December 26, 2012

Recall Number: Z-0605-2013

Event ID: 61734

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.

Status: Terminated

Product Quantity: 1,229 Pumps total

Code Information:

Catalog number - Side Step Set: 3015159. See firm's website - www.medrad.com for specific serial and lot numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated