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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-0293-2010 - 55CM DECATHLON STD KIT
Models: DE50SH55 and DE50SH55-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-0314-2010 - 55CM DECATHLON GOLD STD KIT
Models: DEC50SH55 and DEC50SH55-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated 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-0299-2010 - 55CM DECATHLON FUNNEL TIP STD KIT
Model: DF50SH55
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-0335-2010 - 55CM ALTA LR GOLD STD KIT
Model: ALC50SH55
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. K...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0292-2010 - 40CM DECATHLON STD KIT
Models: DE35SH40 and DE35SH40-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis.
|
2
|
11/17/2009
|
Spire Biomedical, Inc.
|
Z-0313-2010 - 40CM DECATHLON GOLD STD KIT
Models: DEC35SH40 and DEC35SH40-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chro...
|
2
|
11/17/2009
|
Spire Biomedical, Inc.
|
Z-0298-2010 - 40CM DECATHLON FUNNEL TIP STD KIT
Model: DF35SH40
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-0322-2010 - 40CM ALTA LR STANDARD KIT
Model: AL35SH40
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis...
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2
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11/17/2009
|
Spire Biomedical, Inc.
|
Z-0334-2010 - 40CM ALTA LR GOLD STD KIT
Model: ALC35SH40
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-0291-2010 - 36CM DECATHLON STD KIT
Models: DE31SH36 and DE31SH36-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit 28c...
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2
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11/17/2009
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Spire Biomedical, Inc.
|