Recall Z-0060-2010 ยท CAN Regulator, Pressure, Gas Cylinder
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.
| Date | Oct 15, 2009 (initiated Aug 10, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.