MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model

Hazard

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

Details from the source

Reason for recall: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. Quantity: 2420 units Lot/code info: 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;

UPC codes

10193489958447, 40193489958448, 10195327072735, 40195327072736, 10889942849314, 40889942849315, 10816982023398, 40816982023399

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.