FDAFDA · Food and drugs·Recall number Z-1121-2014
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
Published March 5, 2014 · Recall initiated: February 6, 2014
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
Incorrect master label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Vascular
- Distributor
- Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
- Lot
- Lot Number: 50755851
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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