Medrad Continuum MR Infusion System with Wireless Remote Accessory

• • Terminated Z-1673-2014 FDA Class II ·initiated 3 Apr 2014

  There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.

• • Terminated Z-0595-2013 FDA Class II ·initiated 18 Apr 2012

  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.

510(k) Number

K073051 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K952235 Active Cleared 26 Jun 1995

• Medrad Phased Array 1.5T Shoulder Imaging Surface Coil

  Class II

  FDA 510(k) K960901 Active Cleared 29 May 1996

• Benzalkonium-Heparin Coated Guidewires

  Class II

  FDA 510(k) K802473 Active Cleared 12 Nov 1980

• Medrad Counterpoise System

  Class II

  FDA 510(k) K944983 Active Cleared 29 Nov 1994

• Medrad Fluoroscopic Video Enhancement System

  Class II

  FDA 510(k) K884317 Active Cleared 20 Dec 1988

• Mrinnervu Endorectal Prostate Coil

  Class II

  FDA 510(k) K925029 Active Cleared 19 May 1993

See all devices from Medrad, Inc. →

• What is the Medrad Continuum MR Infusion System with Wireless Remote Accessory used for?

  The Medrad Continuum MR Infusion System with Wireless Remote Accessory is an infusion pump designed for use during magnetic resonance (MR) procedures. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile in general hospital settings.

• Is the Medrad Continuum MR Infusion System with Wireless Remote Accessory reusable or single-use?

  The Medrad Continuum MR Infusion System with Wireless Remote Accessory is supplied as a reusable device, meaning it is designed for multiple uses over time. It requires annual calibration by a Medrad service representative to maintain proper function and accuracy in clinical use.

• What regulatory pathway was used for the Medrad Continuum MR Infusion System with Wireless Remote Accessory?

  The Medrad Continuum MR Infusion System with Wireless Remote Accessory is regulated under FDA 510(k) clearance (K073051) with product code FRN and regulation number 880.5725. It was determined to be substantially equivalent to a predicate device through an abbreviated 510(k) submission.