Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. The device is a medical gas yoke assembly which

FDA device recall Z-0059-2010 · posted 2009-10-15 · Terminated

Recall details

Recalling firm

Western - a Scott Fetzer Company

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

CAN

Quantity affected

18 cart assemblies containing 72 yoke assemblies (36 Oxygen yokes and 36 Nitrous Oxide yokes)

Distribution

Nationwide Distribution -- AL, AR, CA, CO, FL, GA, HI, IL, IN, MA, OH, OR, PA, TX, WA and WI.

Date initiated

2009-08-10

Date posted

2009-10-15

Date terminated

2012-04-25

Location

Westlake, OH