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U.S. Department of Health and Human Services

Medical Device Recalls

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31 to 40 of 48 Results
510(K) Number: K040509
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Product Description
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28CM DECATHLON FUNNEL TIP STD KIT Model: DF23SH28 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twi... 2 11/17/2009 Spire Biomedical, Inc.
28CM DECATHLON FUNNEL TIP CATHETER Model: DF23SH28-100 DECATHLON FUNNEL TIP - CATHETER ONLY 15.... 2 11/17/2009 Spire Biomedical, Inc.
28CM DECATHLON EXCHANGE KIT Model: DX23SH28-XP DECATHLON MINI KIT 15.5 Fr polyurethane twin lum... 2 11/17/2009 Spire Biomedical, Inc.
28CM ALTA LR STANDARD KIT High Flow Recirculation Model: AL23SH28 ALTA CATHETER WITH SIDE HOLES... 2 11/17/2009 Spire Biomedical, Inc.
28CM ALTA LR STANDARD KIT Model: AL23NH28 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane... 2 11/17/2009 Spire Biomedical, Inc.
28CM ALTA LR GOLD STD KIT Model: ALC23SH28 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip he... 2 11/17/2009 Spire Biomedical, Inc.
28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fix... 2 11/17/2009 Spire Biomedical, Inc.
24CM DECATHLON STD KIT Models: DE19SH24 and DE19SH24-K 15.5 Fr Polyurethane twin lumen hemodialysi... 2 11/17/2009 Spire Biomedical, Inc.
24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodi... 2 11/17/2009 Spire Biomedical, Inc.
24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K DECATHLON GOLD 15.5 Fr polyureth... 2 11/17/2009 Spire Biomedical, Inc.
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