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U.S. Department of Health and Human Services

Class 2 Device Recall Post Medical Valves

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 Class 2 Device Recall Post Medical Valvessee related information
Date Initiated by FirmMarch 27, 2009
Date PostedSeptember 11, 2009
Recall Status1 Terminated 3 on May 17, 2011
Recall NumberZ-2011-2009
Recall Event ID 51726
Product Classification Cylinder, compressed gas, and valve - Product Code ECX
ProductPost Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.
Code Information Batch Numbers: 08-05-3B and 09-01-1B.
FEI Number 3004485387
Recalling Firm/
Manufacturer		 Intermed Gas Products Corporation
20283 State Road 7
Boca Raton FL 33498-6901
For Additional Information ContactLaurie J. Misner
561-483-1364
Manufacturer Reason
for Recall		Firm received reports from customers that valves malfunctioned when installation and/or filling process. Customers forwarded pictures of the defect where the top portion of the packing nut broke off from the threaded portion of the net; which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
FDA Determined
Cause 2		Component design/selection
ActionIntermed Gas Products Corporation notified customers of the affected product by phone beginning March 27, 2009 and followed up with a formal "Product Recall Notice" letter dated March 31, 2009. All affected product should be located and returned to the firm for replacement. For further information, contact Intermed Gas Products at 1-561-483-1364.
Quantity in Commerce8,767
DistributionNationwide Distribution -- FL, SC, TX, MO, TN, NC, NY, GA, MN, AZ.
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.
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