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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 48 Results
510(K) Number: K032061
 
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55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr Polyurethane twin lumen hemodia... 2 11/17/2009 Spire Biomedical, Inc.
55CM DECATHLON GOLD STD KIT Models: DEC50SH55 and DEC50SH55-K DECATHLON GOLD 15.5 Fr polyuretha... 2 11/17/2009 Spire Biomedical, Inc.
55CM DECATHLON FUNNEL TIP STD KIT Model: DF50SH55 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twi... 2 11/17/2009 Spire Biomedical, Inc.
55CM ALTA LR GOLD STD KIT Model: ALC50SH55 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip ... 2 11/17/2009 Spire Biomedical, Inc.
40CM DECATHLON STD KIT Models: DE35SH40 and DE35SH40-K 15.5 Fr Polyurethane twin lumen hemodialys... 2 11/17/2009 Spire Biomedical, Inc.
40CM DECATHLON GOLD STD KIT Models: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr polyuretha... 2 11/17/2009 Spire Biomedical, Inc.
40CM DECATHLON FUNNEL TIP STD KIT Model: DF35SH40 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twi... 2 11/17/2009 Spire Biomedical, Inc.
40CM ALTA LR STANDARD KIT Model: AL35SH40 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane tw... 2 11/17/2009 Spire Biomedical, Inc.
40CM ALTA LR GOLD STD KIT Model: ALC35SH40 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip ... 2 11/17/2009 Spire Biomedical, Inc.
36CM DECATHLON STD KIT Models: DE31SH36 and DE31SH36-K 15.5 Fr Polyurethane twin lumen hemodialysi... 2 11/17/2009 Spire Biomedical, Inc.
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