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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-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-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-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...
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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-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.
|
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-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...
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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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