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U.S. Department of Health and Human Services

Class 2 Device Recall ARROWgard Blue PLUS Pressure Injectable TwoLumen CVC Kit

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  Class 2 Device Recall ARROWgard Blue PLUS Pressure Injectable TwoLumen CVC Kit see related information
Date Initiated by Firm January 02, 2015
Date Posted February 10, 2015
Recall Status1 Terminated 3 on October 25, 2016
Recall Number Z-1082-2015
Recall Event ID 70175
510(K)Number K071538  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Code Information product number CDC-42802-P1A, lot number 23F14A0063
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall		 Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
FDA Determined
Cause 2		 Process control
Action An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.
Quantity in Commerce 1195
Distribution Nationwide
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 INTERNATIONAL, INC.
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