CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator recalled
Western / Scott Fetzer is recalling Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator, distributed nationwide in the US. The recall was initiated on 7 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1849-2014
- FDA event ID
- 68466
- Recalling firm
- Western / Scott Fetzer, Westlake, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2014
- FDA classified
- 23 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Apr 2014 | Recall initiated by company | |
| 23 Jun 2014 | Classified by FDA | +77 days |
| 2 Jul 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
Product as listed by the FDA
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Where it was distributed
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.
Nationwide AlaskaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Why was it recalled?
Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Western / Scott Fetzer
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|---|---|---|---|---|---|
| Device | CLASS II | Digital Vipr Roc-9839 Roberts Oxygen Ready to Use Digital recalled | Western/Scott Fetzer | Device Malfunction | Nationwide |
| Device | CLASS II | Roberts Digital VIPR System (with E-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR (head only) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR System (with E-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
| Device | CLASS II | Western Oxytote DTE Digital VIPR System (with D-size cylinder) recalled | Western/Scott Fetzer | Foreign Material | 4 states |
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