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Devices
Device Recall IV sets with stopcock
Model / Serial
Lot Number 3458321, 3462452, 3465813, 3442569, 3446005, 3450752, 3465816, 3456237, 3486340, 3451451, 3447667, 3447427, 3471329, 3462010, 3447673, 3470589, 3466170, 3462856, 77-979-Y1, 76-113-Y1, 76-114-Y1, 77-981-Y1, 77-259-Y1, 77-023-HE, 77-481-Y1, 78-637-HE, 77-034-HE, 77-222-Y1, 77-341-HE, 77-354-Y1, 77-613-Y1, 77-033-HE, 76-101-Y1, 77-305-HE, 76-059-Y1, 77-149-Y1, 78-466-HE, 79-571-JW, 77-203-Y1
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution and Internationally to TH.
Product Description
SURPLUG MICRO CONNECTOR Item No. 066-C3352; || 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; || 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; || 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; || 3-Way High Flow Stopcock w/Rotating Luer Item No. B4020; || 38" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054; || 300" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer Item No. B4121; || 3 Gang 3-Way Stopcocks w/Rotating Luer Item No. B4154; || 33" Ext Set w/Remv 3-Way Stopcock, Luer Lock Item No. B4171; || 35" (89 cm) Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B4181; || 113" 15 Drop Primary Set w/2 MicroClave, Remv 3 Gang Manifold w/2 1o2, 3 Way Stopcock, Rotating Luer, 1 Ext Item No. B5153; || 131" (333 cm) Appx 17.2 mL, 20 Drop Admin Set w/4 Pre-slit Ports, MicroClave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. B9900-510; || 101" 15 Drop Primary Set w/2 MicroClave, Rotating Luer, 1 Smallbore T-Connector Ext w/Remv 3-Way Stopcock Item No. B99262; || 140" (356 cm) Appx 18.0 ml, 15 Drop Primary Set w/3 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0060; || 140" (356 cm) Appx 17.9 mL, 15 Drop Primary Set w/BCV-Clave, 2 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0143; || 40" Ext Set w/Removable 2 Gang 3-Way Stopcocks, Pre-Pierced Port, Clamp, Rotating Luer Item No. Z1746; || 136" (345 cm) Appx 18.0 ml, 10 Drop Primary Set w/3 Inj Sites, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z2003; || 137" (348cm) Appx 17.5ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 2 Ext Item No. Z2367; || 48" Ext Set w/Remv 3-Way Stopcock, 2 Clave, MicroClave T-Conn, 3 Clamps, Rotating Luer, 1 Ext, Smallbore Item No. Z2722; || 126" 15 Drop Primary Set w/3 MicroClave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 1 Ext Item No. Z2760; || 114" (290 cm) 60 Drop 150ml Burette Set (w/MicroClave Shut Off, Filter), 3 Pre-Slit Ports, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Smallbore Ext Set w/Clave Item No. Z3284; || 3-Way Stopcock w/Rotating Luer Item No. Z3295; || 111" (282 cm) Appx 14.0 ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 3-Way Stopcock, Rotating Luer w/Filter Cap, 1 Ext Item No. Z3705 || The ICU intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
Manufacturer
ICU Medical, Inc.
1 Event
Recall of Device Recall IV sets with stopcock
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Manufacturer
ICU Medical, Inc.
Manufacturer Address
ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
Manufacturer Parent Company (2017)
ICU Medical, Inc.
Source
USFDA
Language
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