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Class 2 Device Recall Post Medical Valves |
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Date Initiated by Firm |
March 27, 2009 |
Date Posted |
September 11, 2009 |
Recall Status1 |
Terminated 3 on May 17, 2011 |
Recall Number |
Z-2011-2009 |
Recall Event ID |
51726 |
Product Classification |
Cylinder, compressed gas, and valve - Product Code ECX
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Product |
Post 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. |
Recalling Firm/ Manufacturer |
Intermed Gas Products Corporation 20283 State Road 7 Boca Raton FL 33498-6901
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For Additional Information Contact |
Laurie J. Misner 561-483-1364
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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.
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FDA Determined Cause 2 |
Component design/selection |
Action |
Intermed 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 Commerce |
8,767 |
Distribution |
Nationwide Distribution -- FL, SC, TX, MO, TN, NC, NY, GA, MN, AZ. |
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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