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U.S. Department of Health and Human Services

Class 2 Device Recall TwoLumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW gard Blue Catheter

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 Class 2 Device Recall TwoLumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW gard Blue Cathetersee related information
Date Initiated by FirmJuly 29, 2010
Date PostedSeptember 25, 2010
Recall Status1 Terminated 3 on July 05, 2012
Recall NumberZ-2492-2010
Recall Event ID 56363
510(K)NumberK820648 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductTwo-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter
Code Information Product # CA-22702, Lot # RF0033779
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.
Quantity in Commerce2
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 = DQY
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