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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-0312-2010 - 36CM DECATHLON GOLD STD KIT
Models: DEC31SH36 and DEC31SH36-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chroni...
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0297-2010 - 36CM DECATHLON FUNNEL TIP STD KIT
Model: DF31SH36
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-0321-2010 - 36CM ALTA LR STANDARD KIT
Model: AL31SH36
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
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Spire Biomedical, Inc.
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Z-0326-2010 - 36CM ALTA LR STANDARD KIT
Model: AL31NH36
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 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-0333-2010 - 36CM ALTA LR GOLD STD KIT
Model: ALC31SH36
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-0290-2010 - 32CM DECATHLON STD KIT
Models: DE27SH32 and DE27SH32-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-0305-2010 - 32CM DECATHLON MINI KIT
Model: DM27SH32
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, 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-0311-2010 - 32CM DECATHLON GOLD STD KIT
Models: DEC27SH32 and DEC27SH32-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.
|
|
Z-0317-2010 - 32CM DECATHLON GOLD FUNNEL TIP STD KIT
Model: DFC27SH32
15.5 Fr polyurethane twin lumen Heparin coated 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.
|
|
Z-0296-2010 - 32CM DECATHLON FUNNEL TIP STD KIT
Model: DF27SH32
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
|
11/17/2009
|
Spire Biomedical, Inc.
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