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Terminated

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

FDA Recall Z-1849-2014 · Posted 2014-06-23

Recall StatusTerminated
Product CodeCAN
Date Initiated2014-04-07
Date Terminated2016-10-14
Product Quantity118,325 units

Reason for Recall

Separation events have occurred, including the VIPR separating from the Aluminum cylinder.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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