Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION KIT, Model Number ECVC1655; e) CVC INSERTION ACCESSORY KIT, Model Number ECVC7880; f) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635B

Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Code information: all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number CVI4880, UDI/DI (EA) 10195327233976, UDI/DI (CS) 40195327233977; Model Number CVI680C, UDI/DI (EA) 10653160992943, UDI/DI (CS) 40653160992944; Model Number DYNDC1786A, UDI/DI (EA) 10193489199116, UDI/DI (CS) 40193489199117; Model Number ECVC1655, UDI/DI (EA) 10653160254935, UDI/DI (CS) 40653160254936; Model Number ECVC7880, UDI/DI (EA) 10195327129613, UDI/DI (CS) 40195327129614; Model Number IVS3635B, UDI/DI (EA) 10653160992660, UDI/DI (CS) 40653160992661

Distribution pattern: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.