FDA Medical Device Recalls (openFDA)
Puritan Medical Products Inc: 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.
- Recall number
- Z-0317-04
- Recalling firm
- Puritan Medical Products Inc
- 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.
- Status
- Terminated
- Initiated
- 2003-12-02
- Posted
- 2004-07-20
- Terminated
- 2004-11-23
- Reason
- Oxygen component is out of specification
- 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
- 60 cylinders
- Distribution
- Distribution was made to medical facilities located in nationwide.
- Lot, serial or model codes
- CS69Q223, Exp. 8/06
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BXH
- Firm FEI
- 1912755
- Firm city
- Overland Park
- Firm state
- KS
- 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