Date Initiated by Firm | March 20, 2017 |
Create Date | June 06, 2017 |
Recall Status1 |
Terminated 3 on December 18, 2018 |
Recall Number | Z-2307-2017 |
Recall Event ID |
76937 |
510(K)Number | K002507 |
Product Classification |
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
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Product | ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access |
Code Information |
Material number CDA-22122-U1A |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
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For Additional Information Contact | 610-378-0131 |
Manufacturer Reason for Recall | The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard Blue antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue antimicrobial surface in decreasing catheterrelated infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
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FDA Determined Cause 2 | Under Investigation by firm |
Action | Arrow International sent an Urgent Medical Device Notification Letter dated April 5, 2017, to affected customers to inform them of the issue. The notice provided safety instructions for using the product and instructed customers to return the enclosed acknowledgement form indicating the notice was received, and fax it to 855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131. |
Quantity in Commerce | unknown-firm reports total devices distributed 43,394 |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FOZ
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