Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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