Reported Mar 5, 2014 · Terminated
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is…
Medtronic Vascular
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Medtronic Vascular · 35-37A Cherry Hill Drive · Danvers, MA · 01923-2565
Is this the product you have?
- Medtronic Everest 20cc Inflation Device
- Model Number and Catalog NumberAC2205P 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
- Lot codes and dates
- Lot Number50755851
- Amount recalled
- 191 devices
Where it was sold
Why it was recalled
Incorrect master label.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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