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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow gard Blue PLUS Central Venous Catheter

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  Class 2 Device Recall Arrow gard Blue PLUS Central Venous Catheter see related information
Date Initiated by Firm March 17, 2017
Date Posted April 10, 2017
Recall Status1 Terminated 3 on March 24, 2020
Recall Number Z-1879-2017
Recall Event ID 76935
510(K)Number K071538  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit.
Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
Code Information Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM  Lot # 13F16L0105, 23F16K0180 and 13F16L0199
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Elizabeth Norwood
866-246-6990
Manufacturer Reason
for Recall		 Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
FDA Determined
Cause 2		 Process control
Action Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to recalls@teleflex.com or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return. For questions regarding this recall call 866-246-6990.
Quantity in Commerce 310 units
Distribution US Distribution to NJ, IL, and PA
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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