ClearanceBrief
Recall Z-0037-2010 ยท CAN Regulator, Pressure, Gas Cylinder

Airgas Puritan Medical

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

DateOct 14, 2009 (initiated Aug 6, 2009)
StatusTerminated
ReasonYoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
Root causeComponent design/selection
ActionAirgas 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.
Quantity208
DistributionNationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.