Recall Z-2412-2011 ยท MSD Catheter, Hemodialysis, Implanted
R4 Vascular Inc
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 Exch
| Date | Jun 6, 2011 (initiated May 3, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root 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 | 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. |
| FDA record | Open on fda.gov |