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Terminated

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.

FDA Recall Z-2412-2011 · Posted 2011-06-06

Recalling FirmR4 Vascular Inc
Recall StatusTerminated
Product CodeMSD
Date Initiated2011-05-03
Date Terminated2012-07-27
Product Quantity2489 kits

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including CA, CO, CT, FL, GA, IL, LA, MD, MA, MN, MS, MO, NJ, NC, OH, PA, SC, TX, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100169DURASPAN HEMODIALYSIS LONG-TERM CATHETERR4 Vascular, Inc. · 2010-02-18K091506DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520R4 Vascular, Inc. · 2010-01-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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