Z-0732-2007

535D-X CF Continuous Flow Cylinder

Name: Z-0732-2007 535D-X CF Continuous Flow 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 535D-X CF Continuous Flow 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-0732-2007
Status: Terminated
Initiated: 2007-01-24
Posted: 2007-04-21
Terminated: 2009-08-27
Recalling firm: Sunrise Medical, Inc.
Product: 535D-X CF Continuous Flow 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 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.

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)