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U.S. Department of Health and Human Services

Class 2 Device Recall MultiLumen Pressure Inejctable Central Venous Cathetization kit with Blue Flex Tip Catheter

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 Class 2 Device Recall MultiLumen Pressure Inejctable Central Venous Cathetization kit with Blue Flex Tip Cathetersee related information
Date Initiated by FirmJuly 29, 2010
Date PostedSeptember 25, 2010
Recall Status1 Terminated 3 on July 05, 2012
Recall NumberZ-2491-2010
Recall Event ID 56363
510(K)NumberK071538 
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
ProductMulti-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features
Code Information Product # ASK-42703-PSBM, Lot # RF9126852
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information ContactChristine Richards
800-523-8446
Manufacturer Reason
for Recall		Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
FDA Determined
Cause 2		Mixed-up of materials/components
ActionThe recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
DistributionThe product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FOZ
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