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U.S. Department of Health and Human Services

Class 2 Device Recall AGI2237 Portable 2 Cylinder Manifold Cart

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  Class 2 Device Recall AGI2237 Portable 2 Cylinder Manifold Cart see related information
Date Initiated by Firm August 06, 2009
Date Posted October 14, 2009
Recall Status1 Terminated 3 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/
Airgas Puritan Medical
Puritan Medical Unit
259 North Radnor Chester Road Suite 100
Radnor PA 19087
For Additional Information Contact Chris Slowik
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 2
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.