Class 2 Device Recall AGI2237 Portable 2 Cylinder Manifold Cart

• Date Initiated by Firm: August 06, 2009
• Date Posted: October 14, 2009
• Recall Status: Terminated on January 26, 2010
• Recall Number: Z-0037-2010
• Recall Event ID: 53081
• Product Classification: medical gas cylinder connectors - Product Code CAN
• Product: AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
• Code Information: All units of model numbers 8065-870 and 8066-910
• Recalling Firm/ Manufacturer: Airgas Puritan Medical; Puritan Medical Unit; 259 North Radnor Chester Road Suite 100; Radnor PA 19087
• For Additional Information Contact: Chris Slowik; 313-550-6234
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.