Atlas FDA

ICU Medical Inc.

369 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch ICU Medical Inc.

RecordFirmDate
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patie recall (Z-2159-2014)ICU Medical, Inc.2014-08-07
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Need recall (Z-2160-2014)ICU Medical, Inc.2014-08-07
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item recall (Z-2161-2014)ICU Medical, Inc.2014-08-07
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Ite recall (Z-2162-2014)ICU Medical, Inc.2014-08-07
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 T recall (Z-2163-2014)ICU Medical, Inc.2014-08-07
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe T recall (Z-2164-2014)ICU Medical, Inc.2014-08-07
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, It recall (Z-2165-2014)ICU Medical, Inc.2014-08-07
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z376 recall (Z-0658-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, P recall (Z-0659-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave, 3 Clamps, Rotating Luer, recall (Z-0660-2014)ICU Medical, Inc.2014-01-09
183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow, Green Rings), 4 Anti-Syphon recall (Z-0661-2014)ICU Medical, Inc.2014-01-09
184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Posi recall (Z-0662-2014)ICU Medical, Inc.2014-01-09
31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2 Anti Syphon Valves, 0.2 recall (Z-0663-2014)ICU Medical, Inc.2014-01-09
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a s recall (Z-0664-2014)ICU Medical, Inc.2014-01-09
17 cm (7'') Ext Set w/NanoClave, 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, Part No. recall (Z-0665-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector, Rotating Luer, P recall (Z-0666-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating recall (Z-0667-2014)ICU Medical, Inc.2014-01-09
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector, recall (Z-0668-2014)ICU Medical, Inc.2014-01-09
8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter, NanoClav recall (Z-0669-2014)ICU Medical, Inc.2014-01-09
78" Ext Set w/Check Valve, CLAVE Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave, NanoClave recall (Z-0670-2014)ICU Medical, Inc.2014-01-09
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Par recall (Z-0671-2014)ICU Medical, Inc.2014-01-09
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Par recall (Z-0672-2014)ICU Medical, Inc.2014-01-09
8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, It recall (Z-0673-2014)ICU Medical, Inc.2014-01-09
10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, I recall (Z-0674-2014)ICU Medical, Inc.2014-01-09
87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clam recall (Z-0675-2014)ICU Medical, Inc.2014-01-09
13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Par recall (Z-0676-2014)ICU Medical, Inc.2014-01-09
14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps, Rota recall (Z-0677-2014)ICU Medical, Inc.2014-01-09
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check recall (Z-0678-2014)ICU Medical, Inc.2014-01-09
8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The recall (Z-0679-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, recall (Z-0680-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Par recall (Z-0681-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotating recall (Z-0682-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connect recall (Z-0683-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave" T-Connector recall (Z-0684-2014)ICU Medical, Inc.2014-01-09
10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" recall (Z-0685-2014)ICU Medical, Inc.2014-01-09
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon recall (Z-0686-2014)ICU Medical, Inc.2014-01-09
78" Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, recall (Z-0687-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, recall (Z-0688-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Par recall (Z-0689-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Pa recall (Z-0690-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. recall (Z-0691-2014)ICU Medical, Inc.2014-01-09
10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotatin recall (Z-0692-2014)ICU Medical, Inc.2014-01-09
10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave", Clamp, Lu recall (Z-0693-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1 recall (Z-0694-2014)ICU Medical, Inc.2014-01-09
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Par recall (Z-0695-2014)ICU Medical, Inc.2014-01-09
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave Clear (Yello recall (Z-0696-2014)ICU Medical, Inc.2014-01-09
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Par recall (Z-0697-2014)ICU Medical, Inc.2014-01-09
30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoCl recall (Z-0698-2014)ICU Medical, Inc.2014-01-09
120" 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, N recall (Z-0699-2014)ICU Medical, Inc.2014-01-09
5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1 recall (Z-0700-2014)ICU Medical, Inc.2014-01-09
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot recall (Z-0701-2014)ICU Medical, Inc.2014-01-09
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 279 recall (Z-0702-2014)ICU Medical, Inc.2014-01-09
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # recall (Z-0703-2014)ICU Medical, Inc.2014-01-09
28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector, Cl recall (Z-0704-2014)ICU Medical, Inc.2014-01-09
6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroCla recall (Z-0705-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave T-Connecto recall (Z-0706-2014)ICU Medical, Inc.2014-01-09
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-S recall (Z-0707-2014)ICU Medical, Inc.2014-01-09
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot recall (Z-0055-2013)ICU Medical, Inc.2012-10-11
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. recall (Z-2128-2012)ICU Medical, Inc.2012-08-02
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Pro recall (Z-2129-2012)ICU Medical, Inc.2012-08-02
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non recall (Z-2130-2012)ICU Medical, Inc.2012-08-02
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit recall (Z-2131-2012)ICU Medical, Inc.2012-08-02
Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with t recall (Z-0592-2012)ICU Medical, Inc.2012-01-11
IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the steril recall (Z-0593-2012)ICU Medical, Inc.2012-01-11
Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for flu recall (Z-2205-2008)ICU Medical, Inc.2008-09-16
Hospira Monitoring Kit (PA Line) with 03ml Flush Device for Saginaw General Hosp. , Item N recall (Z-2206-2008)ICU Medical, Inc.2008-09-16
Hospira Left Heart Kit for Southwestern M.C. , Item Number: 46084053 Indicated for fluid f recall (Z-2207-2008)ICU Medical, Inc.2008-09-16
ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Numbe recall (Z-2208-2008)ICU Medical, Inc.2008-09-16
Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291 recall (Z-1166-2007)ICU Medical, Inc.2007-08-16
← Previous

Track ICU Medical Inc. automatically

Every clearance here is in the API, with alerts when new ones post.