Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2011-2009

Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services...

Intermed Gas Products Corporation / initiated 2009-03-27 / Terminated / root cause: design

Intermed Gas Products Corporation began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2011-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Intermed Gas Products Corporation
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.
Product code
ECX Cylinder, Compressed Gas, And Valve
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
Batch Numbers: 08-05-3B and 09-01-1B.