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U.S. Department of Health and Human Services

Class 2 Device Recall One Way Valve/Male to Female

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  Class 2 Device Recall One Way Valve/Male to Female 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-0580-04
Recall Event ID 28260
Product Classification Valve, Non-Rebreathing - Product Code CBP
Product One Way Valve/Male to Female Flow, 22 mm I.D./22 mm O.D., Ref 396799, 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. 396799; Lot numbers: 010905, 011020, 020305, 020530, 020705, 020925, 030120, 031120, 030325, 030415.
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 13650 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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