FDA Device

AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

Hazard

Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.

What You Should Do

Remedy

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.

Products

AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Brand
Airgas Puritan Medical Puritan Medical Unit
UPC
All units of model numbers 8065-870 and 8066-910

Units Affected

208