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U.S. Department of Health and Human Services

Class 1 Device Recall TwoLumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWgard Blue PLUS (R) Cathe

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  Class 1 Device Recall TwoLumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWgard Blue PLUS (R) Cathe see related information
Date Initiated by Firm November 24, 2009
Date Posting Updated March 05, 2010
Recall Status1 Terminated 3 on January 18, 2012
Recall Number Z-0786-2010
Recall Event ID 53954
510(K)Number K993691  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte)
Code Information Product number ASK-42802-SHB. Lot numbers RF9068926
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Service Department
800-523-8446
Manufacturer Reason
for Recall
Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
Quantity in Commerce 20 kits
Distribution The products were shipped to distributors in GA, MD, and VA.
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 = FOZ and Original Applicant = ARROW INTL., INC.
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