The Recall Desk

FDA (Devices) recall action 86054

ICU Medical, Inc. recalled 99 products on 2020-10-28

The FDA (Devices) publishes a recall like this one as 99 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 99 pages.

Products
99
Announced
2020-10-28
Critical
0
Units
—

Why these products were recalled

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

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

States named across these recalls

1–25 of 99

  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    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 Intravascular Administration Set is a single use, sterile, non-pyrogenic device…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 7-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    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)10887709051048(17)250101(30)50(10)4603246…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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 Intravascular Administration Set is a single use, sterile, non-pyrogenic…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Pressure Infusion Extension Sets

    ICU Medical is recalling specific lots of smallbore pressure infusion extension sets due to a potential manufacturing defect that may inhibit a proper seal.

    Product
    6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062525(17)250101(30)50(10)4558455…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect

    ICU Medical is recalling specific lots of NanoClave Connectors because a manufacturing defect may prevent a proper seal with the spike.

    Product
    NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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)241101(30)50(10)4475297; (01)10887709032153(17)250201(30)50(10)4711598. The…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254; (01)10887709062946(17)250201(30)50(10)4630684…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of 7-inch smallbore extension sets because a manufacturing defect on the NanoClave surface may inhibit a proper seal.

    Product
    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(10)4590834; (01)10887709051055(17)250101(30)50(10)4557481…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave High Pressure Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave high pressure extension sets because a manufacturing defect may prevent a proper seal.

    Product
    7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709071527(17)250101(30)50(10)4603281. The high pressure extension set is a device…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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)250201(30)50(10)4711084. The Intravascular Administration Set is a single…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Stopcock Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave stopcock sets due to a manufacturing defect that may prevent a proper seal.

    Product
    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 Intravascular Administration Set is a single use, sterile, non-pyrogenic device…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666. Administration sets and their accessories are single use, pre-sterilized devices that…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the stopcock from sealing properly.

    Product
    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)250201(30)50(10)4727498. The Intravascular Administration Set is a single use…
    Category
    Distribution
    37 states
  • SevereFDA (Devices)··2020-10-28

    ICU Medical Recalls 114-inch Burette Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 114-inch burette sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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.…
    Category
    Distribution
    37 states
  • ModerateFDA (Devices)··2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    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 Administration Set is a single use, sterile, non-pyrogenic device which…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Extension Sets Due to Seal Defect

    ICU Medical is recalling NanoClave extension sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    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.
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 5.5-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709077758(17)250101(30)50(10)4603285;(01)10887709077758(17)250101(30)50(10)4603285; (01)10887709077758(17)250101(30)50(10)4630700…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    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)250201(30)50(10)4733564. The Intravascular Administration Set is a single…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect

    ICU Medical is recalling specific lots of NanoClave Connectors due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.

    Product
    NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.

    Product
    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 a single use, sterile, non-pyrogenic device which provides access for the…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls NanoClave Pressure Infusion Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave pressure infusion extension sets because a manufacturing defect may prevent a proper seal.

    Product
    9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265. The high pressure…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect

    ICU Medical is recalling APPX 0.75 ml, 6-Port NanoClave Manifold sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    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)10887709070551(17)250101(30)50(10)4558619…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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)10887709066318(17)241201(30)25(10)4537242. The Intravascular Administration Set is a…
    Category
    Distribution
    37 states