Class 2 Device Recall Easy Mate Portable Liquid Oxygen PM2200 Series

• Date Initiated by Firm: October 04, 2006
• Date Posted: November 04, 2006
• Recall Status: Terminated on February 15, 2008
• Recall Number: Z-0153-2007
• Recall Event ID: 36547
• 510(K)Number: K041122
• Product Classification: Liquid Oxygen Container - Product Code BYJ
• Product: Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067
• Code Information: PM2200 Series. Model number 2201. Serial numbers P002892 through P005116
• FEI Number: 2523148
• Recalling Firm/ Manufacturer: Precision Medical, Inc.; 300 Held Dr; Northampton PA 18067-1150
• For Additional Information Contact: James Parker; 610-262-6090
• Manufacturer Reason for Recall: Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.
• FDA Determined Cause: Other
• Action: The recalling firm telephoned the company to inform them of the problem and to make them aware that replacements would be made available starting on 10/16/06.
• Quantity in Commerce: 550 units
• Distribution: The product was shipped to home care providers nationwide
• 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.

• 510(K) Database: 510(K)s with Product Code = BYJ