FDA (Devices) recall action 67166

ICU Medical, Inc. recalled 50 products on 2014-01-15

The FDA (Devices) publishes a recall like this one as 50 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 50 pages.

Products: 50
Announced: 2014-01-15
Critical: 0
Units: 147,975

Why these products were recalled

ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 50

HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.
Product
14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration se
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flu
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.
Product
5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administratio
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administr
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular a
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flu
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for th
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.
Product
78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular ad
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Stopcock Due to Potential Leakage
ICU Medical is recalling specific lots of NanoClave Stopcocks because a small percentage of the devices may leak.
Product
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the v
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an acce
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 1 Ext, Part No. A1000, Item No. SC124 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.
Product
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the ad
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.
Product
6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the ad
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a pa
Category
Distribution
14 states
SevereFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administr
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.
Product
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the a
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.
Product
17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for
Category
Distribution
14 states
HighFDA (Devices)··2014-01-15
ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk
ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.
Product
6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
Category
Distribution
14 states