Z-0317-04

MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No...

Name: Z-0317-04 MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No...
Creator: Puritan Medical Products Inc
Published: 2003-12-02
License: https://open.fda.gov/license/

Puritan Medical Products Company, LLC / initiated 2003-12-02 / Terminated

FDA source

Puritan Medical Products Inc began a recall of MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No. 536053-009, Reference Gas, containing Oxygen 21%... on 2003-12-02. The reason FDA records is "Oxygen component is out of specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0317-04
Status: Terminated
Initiated: 2003-12-02
Posted: 2004-07-20
Terminated: 2004-11-23
Recalling firm: Puritan Medical Products Company, LLC
Product: MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No. 536053-009, Reference Gas, containing Oxygen 21% plus/minus 0.02% Absolute, and Nitrogen: Balance., ED cylinder size. The label shows Manufactured for: Medical Graphics Corporation, St. Paul, MN, as the responsible firm.
Product code: BXH Gauge, Gas Pressure, Cylinder/Pipeline
Reason for recall: Oxygen component is out of specification
FDA root cause: Other
Action: Phone calls were initiated 12/2/03 requesting return of the recalled cylinders. Registered letters dated 12/9/03 were issued as a follow-up to the phone call.
Quantity in commerce: 60 cylinders
Distribution: Distribution was made to medical facilities located in nationwide.
Product codes and lots: CS69Q223, Exp. 8/06

Product code BXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)