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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Puritan Medical Products Inc
Lot Codes / Batch Numbers
CS69Q223, Exp. 8/06
Products Sold
CS69Q223, Exp. 8/06
Puritan Medical Products Inc is recalling MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Pa due to Oxygen component is out of specification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Oxygen component is out of specification
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026