Z-1692-2008

Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A...

Name: Z-1692-2008 Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A...
Creator: Covidien Limited
Published: 2008-03-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-03-21 / Terminated / root cause: manufacturing process

FDA source

Covidien Limited began a recall of Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA on 2008-03-21. The reason FDA records is "Wiring in battery back-up power supply may short and cause thermal damage to ventilator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2008
Status: Terminated
Initiated: 2008-03-21
Posted: 2008-09-16
Terminated: 2008-10-29
Recalling firm: Medtronic, Inc.
Product: Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All customers were notified by Federal Express letter and were contacted by phone through field service engineers. They were told to examine their inventory for any installed or spare part battery assemblies and to remove and quarantine these parts. Any ventilators with installed affected battery assemblies were to be taken out of service.
Quantity in commerce: 6 Ventilators and 151 factory replacement units
Distribution: Nationwide, including one VA facility in IL and two military facilities in NC and NY. No foreign distribution.
Product codes and lots: 4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS

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)