510(k) K964435 ยท FMG Stopcock, I.V. Set
PRIMARY IV SET
| Applicant | Icu Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Apr 2, 1997 |
| Received | Nov 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. IV Non-Dedicated Gravity Administration Sets with drip chambers Open, Classified |
FMG | None listed |
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FMG | None listed |
| Oct 23, 2025 | ICU Medical, Inc. IV Administration sets.
23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359;
23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213;
70" (178 cm) 150 Open, Classified |
FMG | None listed |
| Aug 1, 2022 | ICU Medical, Inc. 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock; Open, Classified |
FMG | None listed |
| Dec 2, 2020 | ICU Medical, Inc. 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for th Terminated |
FMG | None listed |
| Dec 2, 2020 | ICU Medical, Inc. 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non Terminated |
FMG | None listed |
| Dec 2, 2020 | ICU Medical, Inc. 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the Terminated |
FMG | None listed |
| Dec 2, 2020 | ICU Medical, Inc. 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the adminis Terminated |
FMG | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case;
UDI:(01)10887709051024(17)250101(30)50(10)4603240;(01)10887709 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:
(01)10887709051031(17)250101(30)50(10)4 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case;
UDI: (01)10887709052809(17)250101(30)50(10)4599980. Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)50(10)4572718;
(01)1 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051055(17)250101(30)50(1 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI:(01) Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case
UDI:(01)10887709052953(17) Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50(10)4568886;(01)1088 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101(30)50(10)4603262.
Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(01)10887709065069(17) Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotating Luer. 1 unit per Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)250101(30)50(10)45908 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(17)250101(30)50(10)4 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709069340(17)250101(30)50(10)4558471.
The Intravascul Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)4572779; (01)108877090701 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709075334(17 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30)50(10)4557524.
Th Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)50(10)4603290.
The Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit per pouch, 50 multiva Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801;
(01)10887709085227(17)25 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265;
(01 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)4572966;
(01)108877090902 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533;
(01)10887709090245(17)25010 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709097329(17)25 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case.
UDI:(01)10840619082533(17)250101(30)50(10)4605138.
The Intravascular Administration Set is a Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579.
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709084435(17)250101(30)50(10)4549131.
The Intrav Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709070902(17)2 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per pouch, 50 multivac Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case.
UDI:(01)10887709089508(17)250101(30)25(10)4548244.
The Intrava Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641.
The Intravascular Administ Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658.
The Intravascular Adminis Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709087153(17)250101(30)50(10)4556715;
(01)10887709087153(17)250101(30)50(10)4579939;
(01)108 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709088501(17)250201(30)25(10)4733705.
The Intravascular A Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709088518(17)241101(30)25(10)4475764
(01)10887709088518(17)25020 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948;(01)10887709089393( Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709089904(17)250101(30)25(10)4713954.
The Intravascular Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328.
The Intravascular Adminis Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per case.
UDI:(01)108877 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709080796(17)241201(30)50(10)4536743;
(01)10887709080796(17)250101(30)50 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709095298(17)250101(30)25(10)4573460;
(01)10887709095298 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121147(17)250101 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case.
UDI:(01)10887709121154(17)250101(30)25(10)4556714;
(01)10887709121154(17)2 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709067322(17)250101(30)50(10)4565730;
(01)10887709067322(17)250201(30)50(10)4 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709067582(17)241201(30)50(10)4548270;
(01)10887709067582(17)250101(30)50 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709069203(17)250201(30)50(10)4742130;
(01)10887709069203(17)250401(30)50(10)48 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709069524(17)250 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709070551(17)241201(30)50(10)4542066;
(01)10887709070551(17)241201(30)50(10)4549203;
(01)10887 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709088354(17)250101(30)50(10)4557643.
The Intravascular Administratio Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)250101(30)50(10)4573963; Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(17)250101(30)50(10)4 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case.
UDI:(01)10887709121703(17)250201(30)50(10)4723226.
The Intravascular A Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709011691(17)250201( Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709062365(17)250201(30)25(10)4630752.
The Intravascular Administrati Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709014531(17)250101(30)50(10)4603496.
The In Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133.
The Intravascular Administration Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)10887709079877(17)250101(30)5 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780.
The Intravascular Administration Set is Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442.
The Intravascular Administration Set Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10887709051967(17)2502 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841.
The Intravascular Administrati Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case.
UDI:(01)10887709074696(17)250101(30)25(10)4711277;(01)10887709074696(1 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case.
UDI:(01)1088770907 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709032153(17)241 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034959(17)250201(30)25( Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709085814(17)250101(30)50(10)4605676.
CLAVE Neutron is a normally closed, Terminated |
FPA | None listed |
| Jul 1, 2020 | ICU Medical, Inc. REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravasc Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475 Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058 Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016842 Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088 Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074 Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241 Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473 Terminated |
FMG | None listed |
| Oct 4, 2019 | ICU Medical, Inc. REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108 Terminated |
FMG | None listed |
| Aug 20, 2018 | ICU Medical, Inc. ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for Completed |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids fro Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids f Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, ster Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer. Terminated |
FMG | None listed |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext. Terminated |
FMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.