Z-1085-05

Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP

Name: Z-1085-05 Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP
Creator: Puritan Bennett
Published: 2005-04-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-04-20 / Terminated / root cause: supplier

FDA source

Puritan Bennett began a recall of Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP on 2005-04-20. The reason FDA records is "Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1085-05
Status: Terminated
Initiated: 2005-04-20
Posted: 2005-08-06
Terminated: 2012-01-25
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
Root cause tag: supplier
FDA root cause: Other
Action: Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.
Quantity in commerce: 309
Distribution: USA, Canada and Europe.
Product codes and lots: All codes

Product code CBK

K970460Class IINellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. / cleared 1998-04-30

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)