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U.S. Department of Health and Human Services

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

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 Class 1 Recall
MultiLumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWgard Blue PLUS (R) Cathe
see related information
Date Posted March 05, 2010
Recall Status1 Terminated on January 18, 2012
Recall Number Z-0788-2010
Recall Event ID 53954
Premarket Notification
510(K) Number
K993691 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)
Code Information Product number ASK-45703-UVA2. Lot numbers RF9056115, RF9056743, and RF9060775
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 180 kits
Distribution The products were shipped to distributors in GA, MD, and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTL., INC.
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