ICU Medical, Inc. recalls 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psi
Recalled Product
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case. UDI:(01)10887709088190(17)241201(30)50(10)4515232;(01)10887709068350(17)250101(30)50(10)4572761 The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.
Hazard / Issue
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.
Issued by
FDA
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