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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0295-2010 - 28CM DECATHLON FUNNEL TIP STD KIT
Model: DF23SH28
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialys...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0301-2010 - 28CM DECATHLON FUNNEL TIP CATHETER
Model: DF23SH28-100
DECATHLON FUNNEL TIP - CATHETER ONLY
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chro...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0307-2010 - 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
aphe...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0319-2010 - 28CM ALTA LR STANDARD KIT High Flow Recirculation
Model: AL23SH28
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic h...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0324-2010 - 28CM ALTA LR STANDARD KIT
Model: AL23NH28
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...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0331-2010 - 28CM ALTA LR GOLD STD KIT
Model: ALC23SH28
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0328-2010 - 28CM ALTA EXCHANGE KIT
Model: AL23SH28 XP
ALTA EXCHANGE KIT
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex
fre...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0288-2010 - 24CM DECATHLON STD KIT
Models: DE19SH24 and DE19SH24-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis.
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2
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11/17/2009
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Spire Biomedical, Inc.
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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...
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2
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11/17/2009
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Spire Biomedical, Inc.
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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...
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2
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11/17/2009
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Spire Biomedical, Inc.
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