FDAFDA · Food and drugs·Recall number Z-0848-2014
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.
Published February 5, 2014 · Recall initiated: December 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Distributor
- Worldwide Distribution US, Canada and Japan.
- Lot
- Part number 6481779
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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