FDA Device recall Z-0127-2013
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
- FDA Device
- Class II
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class II recall of Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h… by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Mod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0127-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-25 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, VA, WA, WI, WV, WY |
Product
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Reason
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction
Identifiers
| code_info | Catalog number: 16401 and serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003. |
|---|
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-0127-2013%22
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