Class 2 Device Recall HUDSON RCI

• Date Initiated by Firm: August 22, 2007
• Date Posted: December 28, 2007
• Recall Status: Terminated on August 13, 2012
• Recall Number: Z-0211-2008
• Recall Event ID: 45426
• 510(K)Number: K772348
• Product Classification: Nebulizer - Product Code CAF
• Product: HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.
• Code Information: Product Code/Catalog Number: 1770; Lot Numbers: 49069, 50069, 51069, 52069, 53069, 01079, 02079, 03079, 04079, 06079, 12079, 1279R, 13079, 15079, 16079, 17079, 17079R, 18079, 19079, 19079R and 20079. PRODUCT CODE/CATALOG NUMBER: 41770, Lot Numbers: 50069, 52069, 01079, 06079, 16079, 17079, 17079R, and 18079.
• Recalling Firm/ Manufacturer: Teleflex Creek Dr; 4024 Stirrup Creek Dr; Durham NC 27703-9000
• For Additional Information Contact: Janis Wilson; 919-433-4973
• Manufacturer Reason for Recall: Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient)
• FDA Determined Cause: Release of Material/Component prior to receiving test results
• Action: Customers were notified by an Urgent Medical Device Recall letter on/about 08/22/2007. They were instructed to return the affected products to Teleflex Medical or acknowledge that the products no longer exist. In addition, each were instructed to forward the letter if they have further distributed into institutional settings or to homecare patients and retrieve relevant product from those locations. This recall is to the consumer/user level via sub-recall from distributors or direct accounts as per the Recalling firm.
• Quantity in Commerce: 215,656 units
• Distribution: Worldwide: USA, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Germany, Guatemala, India, Mexico, Panama, Peru, Philippines, South Korea, Thailand, United Arab Emirates, and The United Kingdom.
• Total Product Life Cycle: TPLC 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.

• 510(K) Database: 510(K)s with Product Code = CAF