Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use
FDA device recall Z-2046-2012 · posted 2012-07-19 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
- Action taken
- Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 30, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to complete and return a Customer Response Form via fax to 1-800-292-6551. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 461 untis
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republi
- Date initiated
- 2012-06-18
- Date posted
- 2012-07-19
- Date terminated
- 2013-04-12
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS 8000 MODULAR PERFUSION SYSTEM (K915183) | 3M Health Care, Sarns | 1992-07-08 |