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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-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-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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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-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.
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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-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...
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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-0315-2010 - 24CM DECATHLON GOLD FUNNEL TIP STD KIT
Models: DFC19SH24 and DFC19SH24-K
DECATHLON GOLD FUNNEL TIP
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tip...
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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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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
|
Spire Biomedical, Inc.
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