Recall Z-0603-2013— Medrad Inc

Name: FDA recall Z-0603-2013
Creator: U.S. Food and Drug Administration
Published: 2012-04-18

Class II · Terminated

Class II FDA medical device recall by Medrad Inc, initiated 2012-04-18, terminated 2015-08-17. It names one FDA 510(k) clearance: K051499. 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.. Reason: 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..

Recalling firm: Medrad Inc
Classification: Class II
Status: Terminated
Initiated: 2012-04-18
Terminated: 2015-08-17
Firm location: Indianola, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K051499 — INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETMedegen Medical Manufacturing Services·cleared 2005-06-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.