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

26–50 of 99

  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls ChemoClave Sets Due to Potential Seal Defect

    ICU Medical is recalling ChemoClave needle-free transfer sets because a manufacturing defect may prevent a proper seal, potentially allowing contaminants to enter the system.

    Product
    6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits
    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
    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)10840619066014(17)250201(30)50(10)4718521;(01)10840619066014(17)250201(30)50(10)4735100. Administration sets and their acce
    Category
    Distribution
    37 states
  • 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.

    Product
    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 pouch, 50 multivac pouches per case.UDI:(01)10887709066417(17)250101(30)50(10)45
    Category
    Distribution
    37 states
  • 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.

    Product
    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 Administration Set is a single use, sterile, non-pyrogenic device which provides acce
    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; (01)10887709070551(17)250101(30)50(10)
    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 a proper seal, potentially affecting fluid administration.

    Product
    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)250201(30)25(10)4720644. The Intravascular Administration Set is a single use, s
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls 128-inch Primary Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 128-inch primary sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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(30)50(10)4711125;(01)10887709011691(17)250201(30)50(10)4718711. The Intravas
    Category
    Distribution
    37 states
  • ModerateFDA (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 a proper seal.

    Product
    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)250101(30)50(10)4572784. The Intravascular Administration Set is a single us
    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 use,
    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 NanoClave Administration Sets Due to Seal Defect

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

    Product
    11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; (01)10840619059801(17)241201(30)50(10)4514500; (01)10840619059801(17)250201(30)50(10)4727354. Administration sets and their acc
    Category
    Distribution
    37 states
  • 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
    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 Administration Set is a single use, sterile, non-pyrogenic device which provid
    Category
    Distribution
    37 states
  • SevereFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 9-inch Smallbore Bifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    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)241201(30)50(10)4536611;(01)10887709052953(17)250101(30)50(10)4557492 The In
    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, potentially affecting fluid administration.

    Product
    226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619061231(17)250201(30)50(10)4734990. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the
    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 from sealing properly.

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

    ICU Medical Recalls Trifuse Extension Sets Due to Seal Defect

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

    Product
    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)10887709052816(17)241201(30)50(10)4537141 The Intravascular Administration
    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 admi
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Quadfuse Extension Sets Due to Seal Defect

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

    Product
    15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UDI:(01)10840619076174(17)250201(30)50(10)4735112; (01)10840619076174(17)241201(30)50(10)4493240. Administration sets and their accessories are single use, pre
    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, st
    Category
    Distribution
    37 states
  • 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 due to a potential manufacturing defect that may inhibit a proper seal.

    Product
    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)10887709053004(17)250101(30)50(10)4605109;(01)10887709053004(17)250201(30)50(10)4630
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore bifuse extension sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.

    Product
    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. The Intravascular Administration Set is a single use, sterile, non-pyrogenic
    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 si
    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 from sealing properly.

    Product
    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 multivac pouches per case UDI:(01)10887709083889(17)241201(30)50(10)4514845; (01)1088
    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
    6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080390(17)250101(30)50(10)4572792. The high pressure extension set is a de
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-10-28

    ICU Medical Recalls SURPLUG Nano Connectors Due to Manufacturing Defect

    ICU Medical is recalling SURPLUG Nano Connectors because a manufacturing defect on the internal surface of the NanoClave may inhibit a proper seal with the spike.

    Product
    SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to
    Category
    Distribution
    37 states