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Terminated

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.

FDA Recall Z-0317-04 · Posted 2004-07-20

Recalling FirmPuritan Medical Products Inc
Recall StatusTerminated
Product CodeBXH
Date Initiated2003-12-02
Date Terminated2004-11-23
Product Quantity60 cylinders

Reason for Recall

Oxygen component is out of specification

Firm 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.

Root Cause

Other

Distribution Pattern

Distribution was made to medical facilities located in nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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