Z-0060-2010

Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical...

Name: Z-0060-2010 Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical...
Creator: Western - a Scott Fetzer Company
Published: 2009-08-10
License: https://open.fda.gov/license/

Western Enterprises, Inc. / initiated 2009-08-10 / Terminated / root cause: design

FDA source

Western - a Scott Fetzer Company began a recall of Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas... on 2009-08-10. The reason FDA records is "The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0060-2010
Status: Terminated
Initiated: 2009-08-10
Posted: 2009-10-15
Terminated: 2012-04-25
Recalling firm: Western Enterprises, Inc.
Product: Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
Product code: CAN Regulator, Pressure, Gas Cylinder
Reason for recall: The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type.
Root cause tag: design
FDA root cause: Component design/selection
Action: Western Enterprises issued an "Urgent-Device Recall" notification dated August 20, 2009 informing Consignees of the affected product. Consignees are to contact the firm to request backup plates and installation instructions or request an RGA and shipping instructions for return of the manifold block assembly for modification. For further information, contact Western at 1-800-783-7890.
Quantity in commerce: 303 cart assemblies containing 1,212 yoke assemblies (606 Oxygen yokes and 606 Nitrous Oxide yokes)
Distribution: Nationwide Distribution -- AL, AR, CA, CO, FL, GA, HI, IL, IN, MA, OH, OR, PA, TX, WA and WI.
Product codes and lots: Oxygen Yoke Assembly Model # 8065-870, Nitrous Oxide Yoke Assembly Model # 8066-910 Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238

Product code CAN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)