Class 2 Device Recall One Way Valve/Female to Male Flow

• Date Initiated by Firm: February 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 21, 2006
• Recall Number: Z-0581-04
• Recall Event ID: 28260
• Product Classification: Valve, Non-Rebreathing - Product Code CBP
• Product: One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098, Made in Taiwan.
• Code Information: Catalog No.: 396798, Lot numbers: 020305, 010905, 020530, 020705, 020925, 021015, 021115, 030220, 030515, 030415, 030825, 030120.
• Recalling Firm/ Manufacturer: Rusch Inc; 2450 Meadowbrook Pkwy; Duluth GA 30096-4635
• For Additional Information Contact: William Slevin; 770-623-0816
• Manufacturer Reason for Recall: Valve cap may become loose and enter the air circuitry.
• FDA Determined Cause: Other
• Action: Consignees were notified on 2/3/2004 via certified mail and telephone.
• Quantity in Commerce: 13300 pieces
• Distribution: Nationwide and Canada
• 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.