[Recalled] Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%c |
|---|---|
| Brand / manufacturer | Terumo Cardiovascular Systems Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1962-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 June 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Terumo Cardiovascular Systems Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.