FDA Medical Device Recalls (openFDA)
Western a Scott Fetzer Co: Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label.
- Recall number
- Z-0054-04
- Recalling firm
- Western a Scott Fetzer Co
- Product
- Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label.
- Status
- Terminated
- Initiated
- 2003-10-02
- Posted
- 2003-10-24
- Terminated
- 2006-01-06
- Reason
- The demand valve is defective and does not function as intended in the 'Conservative Mode'.
- 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
- 329 units
- Distribution
- The device was distributed nationwide and into China and Japan.
- Lot, serial or model codes
- Unit S/Ns beginning with ''DHE0010xxxxx'' and ''DHE001100001'' thru ''DHE001102881''
- 510(k) numbers
- ["K010747"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 1526809
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28