FDA Device recall Z-0597-2013
Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications a…
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications a… by Medrad, citing bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 30151….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0597-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-18 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medrad |
| Distribution | US |
Product
Medrad(R) Continuum MR Infusion System Secondary Administration Kit 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.
Identifiers
| code_info | Catalog number - Secondary Kit: MIL 200B. See firm's website - www.medrad.com for specific serial and lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2013%22
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