MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number

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: 3,740,814 units in total Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ55252C, UDI/DI (EA)10195327267919, UDI/DI (CS)40195327267910; b) Model Number DYNJ55455A, UDI/DI (EA)10193489386233, UDI/DI (CS)40193489386234; c) Model Number DYNJ55680A, UDI/DI (EA)10889942639786, UDI/DI (CS)40889942639787; d) Model Number DYNJ56038A, UDI/DI (EA)10195327347840, UDI/DI (CS)40195327347841; e) Model Number DYNJ56547C, UDI/DI (EA)10193489879834, UDI/DI (CS)40193489879835; f) Model Number DYNJ57049G, UDI/DI (EA)10195327110390, UDI/DI (CS)40195327110391; g) Model Number DYNJ57049I, UDI/DI (EA)10195327207731, UDI/DI (CS)40195327207732; h) Model Number DYNJ57049J, UDI/DI (EA)10195327290658, UDI/DI (CS)40195327290659; i) Model Number DYNJ57645C, UDI/DI (EA)10195327287412, UDI/DI (CS)40195327287413; j) Model Number DYNJ57760C, UDI/DI (EA)10195327079390, UDI/DI (CS)40195327079391; k) Model Number DYNJ57792C, UDI/DI (EA)10195327209902, UDI/DI (CS)40195327209903; l) Model Number DYNJ58111D, UDI/DI (EA)10193489932928, UDI/DI (CS)40193489932929; m) Model Number DYNJ58111F, UDI/DI (EA)10195327223519, UDI/DI (CS)40195327223510; n) Model Number DYNJ58162, UDI/DI (EA)10889942829330, UDI/DI (CS)40889942829331; o) Model Number DYNJ58178B, UDI/DI (EA)10195327209919, UDI/DI (CS)40195327209910; p) Model Number DYNJ58510A, UDI/DI (EA)10193489817430, UDI/DI (CS)40193489817431; q) Model Number DYNJ59184B, UDI/DI (EA)10193489949100, UDI/DI (CS)40193489949101; r) Model Number DYNJ5930

UPC codes

10195327267919, 40195327267910, 10193489386233, 40193489386234, 10889942639786, 40889942639787, 10195327347840, 40195327347841, 10193489879834, 40193489879835, 10195327110390, 40195327110391, 10195327207731, 40195327207732, 10195327290658, 40195327290659, 10195327287412, 40195327287413, 10195327079390, 40195327079391, 10195327209902, 40195327209903, 10193489932928, 40193489932929, 10195327223519, 40195327223510, 10889942829330, 40889942829331, 10195327209919, 40195327209910, 10193489817430, 40193489817431, 10193489949100, 40193489949101, 10195327058852, 40195327058853, 10195327034078, 40195327034079, 10195327118846, 40195327118847

Source

Official record: FDA (Device enforcement) ↗

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