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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-0302-2010 - 32CM DECATHLON FUNNEL TIP CATHETER
Model: DF27SH32-100
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-0308-2010 - 32CM DECATHLON EXCHANGE KIT
Model: DX27SH32-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-0320-2010 - 32CM ALTA LR STANDARD KIT
Model: AL27SH32
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-0325-2010 - 32CM ALTA LR STANDARD KIT
Model: AL27NH32
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-0332-2010 - 32CM ALTA LR GOLD STD KIT
Model: ALC27SH32
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-0329-2010 - 32CM ALTA EXCHANGE
Model: AL27SH32 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
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2
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11/17/2009
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Spire Biomedical, Inc.
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Z-0289-2010 - 28CM DECATHLON STD KIT
Models: DE23SH28 and DE23SH28-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-0304-2010 - 28CM DECATHLON MINI KIT
Model: DM23SH28
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-0310-2010 - 28CM DECATHLON GOLD STD KIT
Models: DEC23SH28 and DEC23SH28-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-0316-2010 - 28CM DECATHLON GOLD FUNNEL TIP STD KIT
Models: DFC23SH28 and DFC23SH28-K
DECATHLON GOLD FUNNEL TIP
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips,...
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2
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11/17/2009
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Spire Biomedical, Inc.
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