Reported Jul 25, 2012 · Terminated
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and…
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 Ventilator 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 and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
- Lot codes and dates
- serial numbers
266 of 266 codes
265624363443642436434453644537445404454144542445434454444545445464455244553445544455544557445584455944560445614456244563445644456545318453204532145322453234532445325453264532745328453294533045333453344533545336453374533845339453404534145342453434534445345453464573545736457374573845739457404574145742
- serial numbers
- Amount recalled
- 266
Where it was sold
Why it was recalled
Stop using this product now
CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new CareFusion 203, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.