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Z-0604-2013 Class II Terminated

Recalled by Medrad Inc — Indianola, PA

FDA device recall Z-0604-2013 was initiated by Medrad Inc on April 18, 2012 and is designated Class II. 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,… The recall status is terminated (terminated August 17, 2015). Affected quantity: 1,229 Pumps total.

Recall Details

Product Type: Devices
Report Date: December 26, 2012
Initiation Date: April 18, 2012
Termination Date: August 17, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,229 Pumps total

Product Description

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 functioning while either stationary or mobile.

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.

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.

Code Information

Catalog number - Secondary VSA Set: 3015161. See firm's website - www.medrad.com for specific serial and lot numbers.

Other recalls by Medrad Inc

Z-1586-2013 Class II — DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Mo (April 15, 2013)
Z-0870-2013 Class II — MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac c (November 5, 2012)
Z-0597-2013 Class II — Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristalt (April 18, 2012)
Z-0595-2013 Class II — Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for pat (April 18, 2012)
Z-0600-2013 Class II — Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump Syste (April 18, 2012)
Z-0603-2013 Class II — Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump S (April 18, 2012)
Z-0601-2013 Class II — Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump Sys (April 18, 2012)
Z-0605-2013 Class II — Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System (April 18, 2012)
Z-0602-2013 Class II — Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System (April 18, 2012)
Z-0596-2013 Class II — Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristalti (April 18, 2012)