Z-0857-2010

Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341...

Name: Z-0857-2010 Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341...
Creator: CareFusion 203, Inc.
Published: 2010-01-08
License: https://open.fda.gov/license/

Pulmonetic Systems, Inc. / initiated 2010-01-08 / Terminated / root cause: design

FDA source

CareFusion 203, Inc. began a recall of Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent... on 2010-01-08. The reason FDA records is "CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0857-2010
Status: Terminated
Initiated: 2010-01-08
Posted: 2010-02-25
Terminated: 2011-12-17
Recalling firm: Pulmonetic Systems, Inc.
Product: Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.
Root cause tag: design
FDA root cause: Component design/selection
Action: CareFusion issued an "Urgent Medical Device Recall notification" letter dated January 07, 2010. The letter was addressed to the Director of Respiratory Care describing the problem and the product. Consignees were told that a Service Representative will contact them to arrange for the prompt return of the affected product for correction. For further information, contact CareFusion Technical Support at 1-800-231-2446, Option 1.
Quantity in commerce: 9
Distribution: MN
Product codes and lots: Serial number# 33600, 33604, 33619, 35063, 35068, 35071, 35072, 35073, 35074.

Product code CBK

K070594Class IIPalmtop Ventilator, Models Ptv-8, Ptv-10Pulmonetic Systems, Inc. / cleared 2007-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)