Z-0731-2007

DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder

Name: Z-0731-2007 DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
Creator: Sunrise Medical
Published: 2007-01-24
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2007-01-24 / Terminated

FDA source

Sunrise Medical began a recall of DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder on 2007-01-24. The reason FDA records is "Cylinder could lose oxygen at high pressure after the filling process". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0731-2007
Status: Terminated
Initiated: 2007-01-24
Posted: 2007-04-21
Terminated: 2009-08-27
Recalling firm: Sunrise Medical, Inc.
Product: DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
Product code: NFB Conserver, Oxygen
Reason for recall: Cylinder could lose oxygen at high pressure after the filling process
FDA root cause: Other
Action: The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
Quantity in commerce: 4,169 units (Z-0731/0732-2007)
Distribution: Worldwide-original shipments to distributors/dealers USA and Canada.
Product codes and lots: Model PD1000A-M4, serial numbers 06AM4111006 through 06AM4111055; Model PD1000A-M6, serial numbers 06AM6111008 through 06AM6114328; Model PD1000A-ML6, serial numbers 06AML111006 through 06AML111922; Model PD1000A-C, serial numbers 06AC0111001 through 06AC0111191; Model PD1000A-D, serial numbers 06AD0111011 through 06AD0111132; and Model PD1000A-E, serial numbers 06AE0111006-06AE0111267.

Product code NFB

K020329Class IIDevilbiss Pd1000Sunrise Medical Hhg, Inc. / cleared 2002-06-19

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)