Drug recall
Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and…
FDA recall event 61734 · Class II · Medrad Inc
Key facts
| Event ID | 61734 |
|---|---|
| Recall numbers | Z-0595-2013, Z-0596-2013, Z-0597-2013, Z-0598-2013, Z-0599-2013, Z-0600-2013, Z-0601-2013, Z-0602-2013, Z-0603-2013, Z-0604-2013, Z-0605-2013 |
| Recalling firm | Medrad Inc |
| Product type | Devices |
| Products | Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly…, Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion…, Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide…, Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion…, Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide… and 6 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 18, 2012 |
| Report date | Dec 26, 2012 |
| Termination date | Aug 17, 2015 |
| City | Indianola |
| State | PA |
| Country | United States |
| FEI number | 2520313 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: