Sarns Modular Perfusion System 9000 recall
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for…
Why was Sarns Modular Perfusion System 9000 recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number 164290 and serial number 1005-5463
- Product
- Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 286 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.
- Recall date
- July 25, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)