Terumo Advanced Perfusion System 1 Electronic O2 recall
Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and…
Why was Terumo Advanced Perfusion System 1 Electronic O2 recalled?
Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
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: 801188 and Serial numbers: 0001-0006, 0008-00050, 00052-00123,00125-00152, 00154-0174,00176-00211, 00213-00241, 00245-00250, 00300-00356, 00358-00365, 00367-00449, 00451-00489, 00492-00522, 00524-00531, 00533-00649, 00651-00660, 00662-00825,0826-0830, 00831-01157, and 01160-01164.
- Product
- Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 1095 Units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
- Recall date
- July 18, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)