Recall Z-0316-2010 ยท MSD Catheter, Hemodialysis, Implanted
Spire Biomedical, Inc.
28CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC23SH28 and DFC23SH28-K DECATHLON GOLD FUNNEL TIP 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr
| Date | Nov 17, 2009 (initiated Oct 23, 2009) |
| Status | Terminated |
| Reason | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira |
| Root cause | Process control |
| Action | Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635. |
| Quantity | 1424 units |
| Distribution | Worldwide distribution - Nationwide, Government. Foreign: Canada, France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032061 | DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH Spire Biomedical, Inc., Dec 23, 2003 |
| K040509 | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 Spire Biomedical, Inc., Apr 19, 2004 |
| K042858 | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS Spire Biomedical, Inc., Dec 3, 2004 |
| K060155 | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS Spire Biomedical, Inc., May 9, 2006 |
| K063431 | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 Spire Biomedical, Inc., Jan 29, 2007 |
| K063441 | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 Spire Biomedical, Inc., Feb 12, 2007 |