Z-0055-04

Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the...

Name: Z-0055-04 Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the...
Creator: Western a Scott Fetzer Co
Published: 2003-10-02
License: https://open.fda.gov/license/

Western Enterprises, Inc. / initiated 2003-10-02 / Terminated

FDA source

Western a Scott Fetzer Co began a recall of Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label on 2003-10-02. The reason FDA records is "The demand valve is defective and does not function as intended in the 'Conservative Mode'". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0055-04
Status: Terminated
Initiated: 2003-10-02
Posted: 2003-10-24
Terminated: 2006-01-06
Recalling firm: Western Enterprises, Inc.
Product: Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label.
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: The demand valve is defective and does not function as intended in the 'Conservative Mode'.
FDA root cause: Other
Action: The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.
Quantity in commerce: 1,537 units
Distribution: The device was distributed nationwide and into China and Japan.
Product codes and lots: Unit S/Ns beginning with ''DHE0010xxxxx'' and ''DHE001100001'' thru ''DHE001102881''

Product code BZD

K010747Class IIOpc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, Mdl-7609, Mem-7612, Opc-830Western Ent. / cleared 2001-05-16

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)