Z-0444-2007

Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA...

Name: Z-0444-2007 Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA...
Creator: Puritan Bennett Corporation
Published: 2006-08-31
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-08-31 / Terminated

FDA source

Puritan Bennett Corporation began a recall of Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD on 2006-08-31. The reason FDA records is "Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0444-2007
Status: Terminated
Initiated: 2006-08-31
Posted: 2007-01-09
Terminated: 2014-03-05
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Reason for recall: Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
FDA root cause: Other
Action: Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.
Quantity in commerce: 7,754 (in US)
Distribution: Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.
Product codes and lots: All units are subject to this notice (all serial numbers).

Product code MNT

K003075Class IIKnightstar 330 VentilatorMallinckrodt, Inc. / cleared 2001-12-11

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)