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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow TwoLumen CVC Kit with Blue Flex Tip Catheter

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 Class 2 Device Recall Arrow TwoLumen CVC Kit with Blue Flex Tip Cathetersee related information
Date Initiated by FirmJuly 31, 2013
Date PostedAugust 14, 2013
Recall Status1 Terminated 3 on April 28, 2015
Recall NumberZ-1965-2013
Recall Event ID 65829
510(K)NumberK862056 
Product Classification Catheter, percutaneous - Product Code DQY
ProductArrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Code Information Catalog # AK-17702-CDC, lot # RF2083258
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information ContactCustomer Support
800-343-2935
Manufacturer Reason
for Recall		Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
FDA Determined
Cause 2		Labeling Change Control
ActionAn "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.
Quantity in Commerce156
DistributionAL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
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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