Class 2 Device Recall 4Way TPiece

• Date Initiated by Firm: February 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 21, 2006
• Recall Number: Z-0578-04
• Recall Event ID: 28260
• Product Classification: Valve, Non-Rebreathing - Product Code CBP
• Product: 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea.
• Code Information: Catalog No.: 395945, Lot numbers: 116040, 116039, 114795, 113887, 113886, 113232, 113230, 113095, 113027, 119110, 118134, 119988, 119989, 129179, 128393, 128028, 126119, 126118, 124951, 123197, 123198, 122461, 122033, 131793, 120731
• 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: 4060 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.