Terumo Cardiovascular Systems Corporation Recall: Perfusion System 8000, base 4 pump, 100V
Terumo Cardiovascular Systems Corporation Recall: Perfusion System 8000, base 4 pump, 100V is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Terumo Cardiovascular Systems Corporation; Product: Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion S
| Recalling firm | Terumo Cardiovascular Systems Corporation |
|---|---|
| Product | Perfusion System 8000, base 4 pump, 100V 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 for recall | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardio |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL |
| Recall initiated | 20120925 |
| Recall number | Z-0284-2013 |
| Category | device |
| State | MI |
| Country | United States |
$29/mo
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