Reported Oct 1, 2014 · Terminated
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require…
CareFusion 203, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: CareFusion 203, Inc. · 17400 Medina Rd Ste 100 · Minneapolis, MN · 55447-1341
Is this the product you have?
- CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
- Lot codes and dates
- SERIAL #
- ENVE CUSTOMER UNITS
375 of 375 codes
265624455444559453174532245324453284533045333453344533645339453414534345736457374574045741457424574445745457504575145752459074590846040460414604346044460504605146632466364664146642466434664446645466464706947071470734707547076470774707847079470804708147082472104721147213472144721547216472174721947221
- REVEL CUSTOMER UNITSSERIAL #
1,015 of 1,015 codes
483814838448386483874838948390483914839648397483994840048401484044840548406484074840848409484105036050361503625036350364503655036650367503685036950370503715037350374503755037650378503795038250386503875038850389506185061950623506245062550626506275062850629506305063150632506335063450635506385063950641
- Amount recalled
- 1729
Where it was sold
Why it was recalled
Stop using this product now
CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre
Using this product could cause serious injury, illness or death — stop using it now.
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