Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medical Gas Yoke Assembly

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medical Gas Yoke Assemblysee related information
Date Initiated by FirmAugust 10, 2009
Date PostedOctober 15, 2009
Recall Status1 Terminated 3 on April 25, 2012
Recall NumberZ-0059-2010
Recall Event ID 52847
Product Classification Regulator, pressure, gas cylinder - Product Code CAN
ProductMedical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. 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.
Code Information Oxygen Yoke Assembly Model # 8065-870, Nitrous Oxide Yoke Assembly Model # 8066-910 Generic 4-cylinder Manifold Cart Model #8070
FEI Number 1526809
Recalling Firm/
Manufacturer		 Western - a Scott Fetzer Company
875 Bassett Rd
Westlake OH 44145-1142
For Additional Information ContactDavid C. Simo
440-871-2160 Ext. 2103
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionWestern 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 Commerce18 cart assemblies containing 72 yoke assemblies (36 Oxygen yokes and 36 Nitrous Oxide yokes)
DistributionNationwide Distribution -- AL, AR, CA, CO, FL, GA, HI, IL, IN, MA, OH, OR, PA, TX, WA and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-