• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Easy Mate Portable Liquid Oxygen PM2200 Series

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Easy Mate Portable Liquid Oxygen PM2200 Seriessee related information
Date Initiated by FirmOctober 04, 2006
Date PostedNovember 04, 2006
Recall Status1 Terminated 3 on February 15, 2008
Recall NumberZ-0153-2007
Recall Event ID 36547
510(K)NumberK041122 
Product Classification Liquid Oxygen Container - Product Code BYJ
ProductPrecision 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 ContactJames 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
ActionThe 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 Commerce550 units
DistributionThe product was shipped to home care providers nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BYJ
-
-