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
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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 |
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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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510(K) Database | 510(K)s with Product Code = BYJ
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