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U.S. Department of Health and Human Services

Class 2 Device Recall 4Way TPiece

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  Class 2 Device Recall 4Way TPiece see related information
Date Initiated by Firm February 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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 2		 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.
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