Class 2 Device Recall DuraspanTM Dialysis Catheters, Ultra and Long Term

• Date Initiated by Firm: May 03, 2011
• Date Posted: June 06, 2011
• Recall Status: Terminated on July 27, 2012
• Recall Number: Z-2412-2011
• Recall Event ID: 58735
• 510(K)Number: K091506 K100169
• Product Classification: Catheter, hemodialysis, implanted - Product Code MSD
• Product: DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369.; ; ; Description Model #; Duraspan Kit - 24cm 62152420; Duraspan Kit - 28cm 62152820; Duraspan Kit - 32cm 62153220; Duraspan Exchange Kit - 32cm 62153228; Duraspan Kit - 36cm 62153620; Duraspan Exchange Kit - 36cm 62153628; Duraspan Kit - 40cm 62154020; Duraspan Exchange Kit - 40cm 62154028; Duraspan Kit - 55cm 62155520; Duraspan Ultra Kit - 24cm 621524E0; Duraspan Ultra Kit - 28cm 621528E0; Duraspan Ultra Kit - 36cm 621536E0; Duraspan Ultra Kit - 40cm 621540E0; Duraspan Ultra Kit - 55cm 621555E0; ; The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.
• Code Information: 42 Lots Total in total: R401D035P R401D049P R401D053P R401D055P R401D056P R401D057P R401D060P R401D092P R401D097P R401D098P R401D099P R401D102P R401D123P R401D124P R401D125P R401D126P R401D169P R401D217P R401D218P R401D250P R401D251P R402D050P R402D056P R402D057P R402D097P R402D102P R402D130P R402D138P R402D162P R402D168P R402D217P R402D250P R403D057P R403D097P R403D123P R403D140P R403D159P R403D196P R403D217P R404D057P R404D196P D405D057P
• Recalling Firm/ Manufacturer: R4 Vascular Inc; 7550 Meridian Cir N Ste 150; Maple Grove MN 55369-4932
• For Additional Information Contact: 201-394-2708
• Manufacturer Reason for Recall: r4 Vascular, Inc. is conducting a voluntary recall of specific lots of Duraspan Dialysis Catheters. Duraspan catheters are 15.5 Fr dual lumen chronic hemodialysis catheters. Over a six month period, seven patients at five hospitals experienced separation of the luer connector from the extension tube on the Duraspan catheter. Testing during failure analysis disclosed that these lots and other lot
• FDA Determined Cause: Nonconforming Material/Component
• Action: R4 Vascular Inc sent an Urgent Medical Device Recall letter dated May 3, 2011, to all affected customers. The letter described the problem and the product being recalled. Consignees were instructed to stop distributing the product and to quarantine the recalled lots and if they had already distributed the affected product to seek its return from their customers. A template letter to physicians and healthcare facilities was enclosed for Distributors/Retailers to send or hand deliver to their customers. For questions regarding this recall call 1-704-905-2105.
• Quantity in Commerce: 2489 kits
• Distribution: Nationwide Distribution including CA, CO, CT, FL, GA, IL, LA, MD, MA, MN, MS, MO, NJ, NC, OH, PA, SC, TX, and WA.
• 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 = MSD and Original Applicant = R4 VASCULAR, INC.