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ICU Medical Inc.

369 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Transpac Disposa recall (Z-0517-2017)ICU Medical, Inc.2016-11-15
CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 The Transpac recall (Z-0518-2017)ICU Medical, Inc.2016-11-15
CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT recall (Z-0519-2017)ICU Medical, Inc.2016-11-15
CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. recall (Z-0520-2017)ICU Medical, Inc.2016-11-15
SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The Transpac Disp recall (Z-0521-2017)ICU Medical, Inc.2016-11-15
PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 The Transpac recall (Z-0522-2017)ICU Medical, Inc.2016-11-15
QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The recall (Z-0523-2017)ICU Medical, Inc.2016-11-15
TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac recall (Z-0524-2017)ICU Medical, Inc.2016-11-15
TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposabl recall (Z-0525-2017)ICU Medical, Inc.2016-11-15
TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item recall (Z-0526-2017)ICU Medical, Inc.2016-11-15
SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item recall (Z-0527-2017)ICU Medical, Inc.2016-11-15
Cath Lab Kit w/Waste Bag, dyePod, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Dis recall (Z-0528-2017)ICU Medical, Inc.2016-11-15
Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-1 recall (Z-0529-2017)ICU Medical, Inc.2016-11-15
CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, I recall (Z-0530-2017)ICU Medical, Inc.2016-11-15
CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Ite recall (Z-0531-2017)ICU Medical, Inc.2016-11-15
4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46 recall (Z-0532-2017)ICU Medical, Inc.2016-11-15
2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item recall (Z-0533-2017)ICU Medical, Inc.2016-11-15
Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way S recall (Z-0534-2017)ICU Medical, Inc.2016-11-15
DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable S recall (Z-0535-2017)ICU Medical, Inc.2016-11-15
Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac Disp recall (Z-0536-2017)ICU Medical, Inc.2016-11-15
CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight Pr recall (Z-0537-2017)ICU Medical, Inc.2016-11-15
Transpac 4 kit w/72" Macrodrip Admin Set, Item No. 46099-77 The Transpac Disposable Straig recall (Z-0538-2017)ICU Medical, Inc.2016-11-15
5 Port "OFF" Manifold w/TRANSPAC IV, Item No. 46100-29 The Transpac Disposable Straight Pr recall (Z-0539-2017)ICU Medical, Inc.2016-11-15
Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac IV, 72" Spike S recall (Z-0540-2017)ICU Medical, Inc.2016-11-15
Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac IV and recall (Z-0541-2017)ICU Medical, Inc.2016-11-15
TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Ite recall (Z-0542-2017)ICU Medical, Inc.2016-11-15
Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needlele recall (Z-0543-2017)ICU Medical, Inc.2016-11-15
Transpac w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item No. 46101-82 recall (Z-0544-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO FLUS recall (Z-0545-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo Flush and Needl recall (Z-0546-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush a recall (Z-0547-2017)ICU Medical, Inc.2016-11-15
Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Tran recall (Z-0548-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP AND recall (Z-0549-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red recall (Z-0550-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Ite recall (Z-0551-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo Flush, Pall Air Fil recall (Z-0552-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir, Squeeze Flus recall (Z-0553-2017)ICU Medical, Inc.2016-11-15
Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, B recall (Z-0554-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The Tran recall (Z-0555-2017)ICU Medical, Inc.2016-11-15
Bifurcated Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT recall (Z-0556-2017)ICU Medical, Inc.2016-11-15
Trifurcated Transpac IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needlele recall (Z-0557-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml Squeeze Flush Device 1 recall (Z-0558-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and N recall (Z-0559-2017)ICU Medical, Inc.2016-11-15
Transpac IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Res recall (Z-0560-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodr recall (Z-0561-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device a recall (Z-0562-2017)ICU Medical, Inc.2016-11-15
Transpac IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS The recall (Z-0563-2017)ICU Medical, Inc.2016-11-15
Transpac IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac D recall (Z-0564-2017)ICU Medical, Inc.2016-11-15
Transpac IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Devic recall (Z-0565-2017)ICU Medical, Inc.2016-11-15
Transpac IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yel recall (Z-0566-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 4 recall (Z-0567-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Fl recall (Z-0568-2017)ICU Medical, Inc.2016-11-15
Transpac IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stop recall (Z-0569-2017)ICU Medical, Inc.2016-11-15
Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac IV, 2 Admin Sets and 8 cc Control recall (Z-0570-2017)ICU Medical, Inc.2016-11-15
Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac IV, Waste Bag System a recall (Z-0571-2017)ICU Medical, Inc.2016-11-15
4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Dispo recall (Z-0572-2017)ICU Medical, Inc.2016-11-15
Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable Stra recall (Z-0573-2017)ICU Medical, Inc.2016-11-15
CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Tran recall (Z-0574-2017)ICU Medical, Inc.2016-11-15
LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (D recall (Z-0575-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeez recall (Z-2805-2016)ICU Medical, Inc.2016-09-15
Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tub recall (Z-2806-2016)ICU Medical, Inc.2016-09-15
Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valv recall (Z-2807-2016)ICU Medical, Inc.2016-09-15
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Tra recall (Z-2808-2016)ICU Medical, Inc.2016-09-15
Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing recall (Z-2809-2016)ICU Medical, Inc.2016-09-15
Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL S recall (Z-2810-2016)ICU Medical, Inc.2016-09-15
Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Dis recall (Z-2811-2016)ICU Medical, Inc.2016-09-15
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, recall (Z-2812-2016)ICU Medical, Inc.2016-09-15
Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and recall (Z-2813-2016)ICU Medical, Inc.2016-09-15
Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpa recall (Z-2814-2016)ICU Medical, Inc.2016-09-15
Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Dispo recall (Z-2815-2016)ICU Medical, Inc.2016-09-15
Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Trans recall (Z-2816-2016)ICU Medical, Inc.2016-09-15
Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transp recall (Z-2817-2016)ICU Medical, Inc.2016-09-15
Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Dispo recall (Z-2818-2016)ICU Medical, Inc.2016-09-15
SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposa recall (Z-2819-2016)ICU Medical, Inc.2016-09-15
Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transp recall (Z-2820-2016)ICU Medical, Inc.2016-09-15
Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Dispos recall (Z-2821-2016)ICU Medical, Inc.2016-09-15
5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Str recall (Z-2822-2016)ICU Medical, Inc.2016-09-15
Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage recall (Z-2823-2016)ICU Medical, Inc.2016-09-15
Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze F recall (Z-2824-2016)ICU Medical, Inc.2016-09-15
TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item N recall (Z-2825-2016)ICU Medical, Inc.2016-09-15
Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valve recall (Z-2826-2016)ICU Medical, Inc.2016-09-15
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flus recall (Z-2827-2016)ICU Medical, Inc.2016-09-15
Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needl recall (Z-2828-2016)ICU Medical, Inc.2016-09-15
119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroC recall (Z-1588-2015)ICU Medical, Inc.2015-05-07
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non- recall (Z-1589-2015)ICU Medical, Inc.2015-05-07
104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/ recall (Z-1590-2015)ICU Medical, Inc.2015-05-07
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallb recall (Z-1591-2015)ICU Medical, Inc.2015-05-07
108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp recall (Z-1592-2015)ICU Medical, Inc.2015-05-07
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, recall (Z-1593-2015)ICU Medical, Inc.2015-05-07
98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifus recall (Z-1594-2015)ICU Medical, Inc.2015-05-07
98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tu recall (Z-1595-2015)ICU Medical, Inc.2015-05-07
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 F recall (Z-2619-2014)ICU Medical, Inc.2014-09-19
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 F recall (Z-2620-2014)ICU Medical, Inc.2014-09-19
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, recall (Z-2621-2014)ICU Medical, Inc.2014-09-19
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Ro recall (Z-2622-2014)ICU Medical, Inc.2014-09-19
CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged i recall (Z-2293-2014)ICU Medical, Inc.2014-08-20
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are recall (Z-2294-2014)ICU Medical, Inc.2014-08-20
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are recall (Z-2295-2014)ICU Medical, Inc.2014-08-20
Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 recall (Z-2157-2014)ICU Medical, Inc.2014-08-07
Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodr recall (Z-2158-2014)ICU Medical, Inc.2014-08-07
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Every clearance here is in the API, with alerts when new ones post.