Reported Jul 22, 2015 · Terminated
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- The FLOW-i Anesthesia System Axillary O2 and Suction Module
- Device Part number66 79 847
- FLOW-i Anesthesia SystemIs indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended
- for use in a wide range of populationfrom neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration
- Auxiliary O2 and Suction ModuleIs an option available for the FLOW-i Anesthesia System
- The module contains two main partsFlowmeter
- unitThe intended use of the flowmeter is to provide oxygen for patient therapy
- Suction unitThe intended use is to extract body fluids from the stomach and airways
- Lot codes and dates
- Device Part number66 79 847
- Serial Numbers
414-2426-2931374056138199205367369-372391394-395416466-491517519525567-568570582-583606613619627629-631633635-641and 643-665
- Amount recalled
- 104 units
Where it was sold
- Nationwide
Why it was recalled
Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
This product could cause temporary or reversible health problems — stop using it.
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