MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJR

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: 28568 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 1 May 2023: a) Model Number DYNJ81722, UDI/DI (EA) 10195327136437, UDI/DI (CS)40195327136438; b) Model Number DYNJRA0827A, UDI/DI (EA) 10193489214468, UDI/DI (CS)40193489214469; c) Model Number DYNJRA0881, UDI/DI (EA) 10889942463930, UDI/DI (CS)40889942463931; d) Model Number DYNJRA0881A, UDI/DI (EA) 10195327262402, UDI/DI (CS)40195327262403; e) Model Number DYNJRA1603, UDI/DI (EA) 10193489299007, UDI/DI (CS)40193489299008; f) Model Number DYNJRA1739A, UDI/DI (EA) 10193489924954, UDI/DI (CS)40193489924955; g) Model Number DYNJRA1823, UDI/DI (EA) 10193489961881, UDI/DI (CS)40193489961882; h) Model Number DYNJRA1837, UDI/DI (EA) 10193489976717, UDI/DI (CS)40193489976718; i) Model Number DYNJRA1847, UDI/DI (EA) 10193489993660, UDI/DI (CS)40193489993661; j) Model Number DYNJRA1864, UDI/DI (EA) 10195327008789, UDI/DI (CS)40195327008780; k) Model Number DYNJRA1869, UDI/DI (EA) 10195327018818, UDI/DI (CS)40195327018819; l) Model Number DYNJRA1878, UDI/DI (EA) 10195327040376, UDI/DI (CS)40195327040377; m) Model Number DYNJRA1893, UDI/DI (EA) 10195327062828, UDI/DI (CS)40195327062829; n) Model Number DYNJRA1900, UDI/DI (EA) 10195327082253, UDI/DI (CS)40195327082254; o) Model Number DYNJRA1945, UDI/DI (EA) 10195327133054, UDI/DI (CS)40195327133055; p) Model Number DYNJRA1975, UDI/DI (EA) 10195327163242, UDI/DI (CS)40195327163243; q) Model Number DYNJRA1998, UDI/DI (EA) 10195327194291, UDI/DI (CS)40195327194292; r) M

UPC codes

10195327136437, 40195327136438, 10193489214468, 40193489214469, 10889942463930, 40889942463931, 10195327262402, 40195327262403, 10193489299007, 40193489299008, 10193489924954, 40193489924955, 10193489961881, 40193489961882, 10193489976717, 40193489976718, 10193489993660, 40193489993661, 10195327008789, 40195327008780, 10195327018818, 40195327018819, 10195327040376, 40195327040377, 10195327062828, 40195327062829, 10195327082253, 40195327082254, 10195327133054, 40195327133055, 10195327163242, 40195327163243, 10195327194291, 40195327194292, 10195327212049, 40195327212040, 10195327218164, 40195327218165, 10195327225223, 40195327225224

Source

Official record: FDA (Device enforcement) ↗

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