Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1849-2014Class II

Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

Western Enterprises, Inc. / initiated 2014-04-07 / Terminated / root cause: design

Western / Scott Fetzer Company began a recall of Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) on . FDA classified it as Class II and gives the reason as "Separation events have occurred, including the VIPR separating from the Aluminum cylinder". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1849-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Western Enterprises, Inc.
Product
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Product code
CAN Regulator, Pressure, Gas Cylinder
Reason for recall
Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
Root cause tag
design
FDA root cause
Device Design
Action
All initial consignees of subject product were notified by letter dated June 5, 2014 via U.S. mail. Initial consignees were directed to forward copies of the recall notification letters to their contacts in the event the subject product has been further distributed.
Quantity in commerce
118,325 units
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia and the countries of Canada,China, Costa Rica, France, Honduras, India, Ireland, Italy, Japan, Korea (South), Malaysia, Panama, Spain and Taiwan.
Product codes and lots
Model numbers AGI-4430, ALQ-1877, ALQ-1878, ALQ-1967, ALQ-2033, ALQ-2041, INW-5153, PRX-9310, PRX-9415, PRX-9416, PRX-9416L, PRX-9427, PRX-9427L, RG3001, RG3003, RG4004, RG4004B, RMI-9672, VIT-11660, XRA-3100, XRA-3110, XRA-3110F, XRA-3120, XRA-3120F, XRA-3130, XRA-3200, XRA-3220, XRA-3230, XRA-3230F, XRA-3300, XRA-3310, XRA-3320, XRA-3320F, XRA-3330, XRA-3330F, XRA-3400, XRA-3420, XRA-3420F, XRA-3430, XRA-3430F, XRA-4400, XRA-4430, and XRA-4430P.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1849-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1849-2014Class IITerminatedVoluntary: Firm initiated