Carefusion 2200 Inc

FDA Regulatory Profile

Summary

Total Recalls
112 (4 Class I)
510(k) Clearances
14
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2428-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLEJuly 13, 2023
Z-2425-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopJuly 13, 2023
Z-2417-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020July 13, 2023
Z-2418-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7July 13, 2023
Z-2416-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; eJuly 13, 2023
Z-2429-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopJuly 13, 2023
Z-2426-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220;July 13, 2023
Z-2424-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLJuly 13, 2023
Z-2419-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscJuly 13, 2023
Z-2420-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endosJuly 13, 2023
Z-2415-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endosJuly 13, 2023
Z-2423-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endosJuly 13, 2023
Z-2422-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscoJuly 13, 2023
Z-2421-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscoJuly 13, 2023
Z-2427-2023Class IISnowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endosJuly 13, 2023
Z-1421-2023Class II(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3March 16, 2023
Z-1236-2023Class IICD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product nameJanuary 30, 2023
Z-0389-2023Class IICarefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8November 2, 2022
Z-0384-2023Class IICarefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTNovember 2, 2022
Z-0395-2023Class IICareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF November 2, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186March 4, 2021
K163615Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsMay 4, 2017
K162432Multi-Link X2 ECG Cable and Lead Wire SystemJanuary 18, 2017
K160764AirLife Autofill Humidification ChamberAugust 25, 2016
K153554Genesis Low Temperature Reusable Rigid Container SystemMarch 21, 2016
K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic InstrumentsFebruary 1, 2016
K142529Genesis Reusable Rigid Container SystemJanuary 8, 2015
K140850GENESIS REUSABLE RIGID CONTAINER SYSTEMAugust 27, 2014
K140761KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULAApril 21, 2014
K113407SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORSSeptember 7, 2012
K112535GENESIS REUSABLE RIGID CONTAINER SYSTEMApril 27, 2012
K110257DIAMOND-FLEX(R) GRASPERSMay 6, 2011
K102179ENVIEW (TM)December 2, 2010
K093616V. MUELLER CAMERA CONTROLLER WITH STORAGE CARTDecember 23, 2009