ClearanceBrief
Recall Z-0307-2010 ยท MSD Catheter, Hemodialysis, Implanted

Spire Biomedical, Inc.

28CM DECATHLON EXCHANGE KIT Model: DX23SH28-XP DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free.

DateNov 17, 2009 (initiated Oct 23, 2009)
StatusTerminated
ReasonThere 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 causeProcess control
ActionSpire 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.
Quantity97 units
DistributionWorldwide distribution - Nationwide, Government. Foreign: Canada, France.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K032061DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH
Spire Biomedical, Inc., Dec 23, 2003
K040509ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
Spire Biomedical, Inc., Apr 19, 2004
K04285855CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
Spire Biomedical, Inc., Dec 3, 2004
K06343115.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
Spire Biomedical, Inc., Jan 29, 2007
K06344115.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
Spire Biomedical, Inc., Feb 12, 2007