Recall Z-0317-04 ยท BXH Gauge, Gas Pressure, Cylinder/Pipeline
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.
| Date | Jul 20, 2004 (initiated Dec 2, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.