Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0605-2013 — 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

U.S. FDA — Device Enforcement · United States · 2012-04-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0605-2013
Date of alert
2012-04-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medrad Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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