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U.S. Department of Health and Human Services

Class 2 Device Recall AGI2238 Portable 4 Cylinder Manifold Cart

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  Class 2 Device Recall AGI2238 Portable 4 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-0038-2010
Recall Event ID 53081
Product Classification medical gas cylinder connectors - Product Code CAN
Product AGI-2238 Portable 4 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 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.
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