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Class 2 Device Recall Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) |
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Date Initiated by Firm |
April 07, 2014 |
Date Posted |
June 23, 2014 |
Recall Status1 |
Terminated 3 on October 14, 2016 |
Recall Number |
Z-1849-2014 |
Recall Event ID |
68466 |
Product Classification |
Regulator, pressure, gas cylinder - Product Code CAN
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Product |
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Western / Scott Fetzer Company 875 Bassett Rd Westlake OH 44145-1142
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For Additional Information Contact |
Recall Support Group 800-783-7890 Ext. 1516
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Manufacturer Reason for Recall |
Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
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FDA Determined Cause 2 |
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. |
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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