Z-0037-2010
AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders
Airgas Puritan Medical / initiated 2009-08-06 / Terminated / root cause: design
Airgas Puritan Medical began a recall of AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders on . The reason FDA records is "Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0037-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Airgas Puritan Medical
- Product
- AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
- Product code
- CAN Regulator, Pressure, Gas Cylinder
- Reason for recall
- Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
- Root cause tag
- design
- FDA root cause
- Component design/selection
- Action
- Airgas issued a Medical Device Removal letter dated 8/6/09 to its customers informing them of the problem and the need to have a yoke back-up plate installed on the Manifold Block Assembly.
- Quantity in commerce
- 208
- Distribution
- Nationwide distribution.
- Product codes and lots
- All units of model numbers 8065-870 and 8066-910
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