Z-2175-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- May 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2739 units
Product Description
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 for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
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