Z-2196-2023 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
- 2420 units
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;
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: a) Model Number DYNJ44410G. UDI/DI (EA)10193489958447, UDI/DI (CS)40193489958448; b) Model Number DYNJ9048708I. UDI/DI (EA)10195327072735, UDI/DI (CS)40195327072736; c) Model Number PHS762887001B. UDI/DI (EA)10889942849314, UDI/DI (CS) 40889942849315; d) Model Number TVS4700. UDI/DI (EA)10816982023398, UDI/DI (CS)40816982023399;