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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 48 Results
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Z-0327-2010 - 24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free 2 11/17/2009 Spire Biomedical, Inc.
Z-0330-2010 - 24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. K... 2 11/17/2009 Spire Biomedical, Inc.
Z-0323-2010 - 24CM ALTA LR STANDARD KIT Model: AL19NH24 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and ap... 2 11/17/2009 Spire Biomedical, Inc.
Z-0318-2010 - 24CM ALTA LR STANDARD KIT High Flow Recirculation Catheter Model: AL19SH24 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for c... 2 11/17/2009 Spire Biomedical, Inc.
Z-0306-2010 - 24CM DECATHLON EXCHANGE KIT Model: DX19SH24-XP DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and aphe... 2 11/17/2009 Spire Biomedical, Inc.
Z-0300-2010 - 24CM DECATHLON FUNNEL TIP CATHETER Model: DF19SH24-100 DECATHLON FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chro... 2 11/17/2009 Spire Biomedical, Inc.
Z-0294-2010 - 24CM DECATHLON FUNNEL TIP STD KIT Model: DF19SH24 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialys... 2 11/17/2009 Spire Biomedical, Inc.
Z-0315-2010 - 24CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC19SH24 and DFC19SH24-K DECATHLON GOLD FUNNEL TIP 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tip... 2 11/17/2009 Spire Biomedical, Inc.
Z-0309-2010 - 24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chr... 2 11/17/2009 Spire Biomedical, Inc.
Z-0303-2010 - 24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Ki... 2 11/17/2009 Spire Biomedical, Inc.
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