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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 186 Results
510(K) Number: K964435
 
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IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF:... 1 10/23/2025 ICU Medical, Inc.
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Lue... 1 09/19/2014 ICU Medical, Inc.
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating ... 1 09/19/2014 ICU Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Contr... 1 09/19/2014 ICU Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Contr... 1 09/19/2014 ICU Medical, Inc.
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;... 2 09/09/2022 ICU Medical, Inc.
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravasc... 2 02/05/2021 ICU Medical, Inc.
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave® Clear, 1.2 Micron Filter, 2 Clamps, Luer L... 2 02/05/2021 ICU Medical, Inc.
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascu... 2 02/05/2021 ICU Medical, Inc.
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular admi... 2 02/05/2021 ICU Medical, Inc.
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