FDA Medical Device Recalls (openFDA)
Western - a Scott Fetzer Company: 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.
- Recall number
- Z-0060-2010
- Recalling firm
- Western - a Scott Fetzer Company
- 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.
- Status
- Terminated
- Initiated
- 2009-08-10
- Posted
- 2009-10-15
- Terminated
- 2012-04-25
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Oxygen Yoke Assembly Model # 8065-870, Nitrous Oxide Yoke Assembly Model # 8066-910 Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAN
- Firm FEI
- 1526809
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28