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U.S. Department of Health and Human Services

Class 2 Device Recall Easy Mate Portable Liquid Oxygen PM2200 Series

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  Class 2 Device Recall Easy Mate Portable Liquid Oxygen PM2200 Series see related information
Date Initiated by Firm October 04, 2006
Date Posted November 04, 2006
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = PRECISION MEDICAL, INC.
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