MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE 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: # included in 3,740,814 units total Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ67770A, UDI/DI (EA)10195327290979, UDI/DI (CS)40195327290970; b) Model Numbers DYNJ67771, UDI/DI (EA)10193489430721, UDI/DI (CS)40193489430722; c) Model Numbers DYNJ68019, UDI/DI (EA)10193489467840, UDI/DI (CS)40193489467841; d) Model Numbers DYNJ68198, UDI/DI (EA)10193489499179, UDI/DI (CS)40193489499170; e) Model Numbers DYNJ68499B, UDI/DI (EA)10195327034054, UDI/DI (CS)40195327034055; f) Model Numbers DYNJ68667, UDI/DI (EA)10193489837315, UDI/DI (CS)40193489837316; g) Model Numbers DYNJ68863, UDI/DI (EA)10193489845402, UDI/DI (CS)40193489845403; h) Model Numbers DYNJ68880, UDI/DI (EA)10193489847727, UDI/DI (CS)40193489847728; i) Model Numbers DYNJ68933, UDI/DI (EA)10193489860375, UDI/DI (CS)40193489860376; j) Model Numbers DYNJ68968A, UDI/DI (EA)10195327206840, UDI/DI (CS)40195327206841; k) Model Numbers DYNJ68990A, UDI/DI (EA)10193489981360, UDI/DI (CS)40193489981361; l) Model Numbers DYNJ69009A, UDI/DI (EA)10195327075569, UDI/DI (CS)40195327075560; m) Model Numbers DYNJ69108A, UDI/DI (EA)10195327025717, UDI/DI (CS)40195327025718; n) Model Numbers DYNJ69272A, UDI/DI (EA)10195327015800, UDI/DI (CS)40195327015801; o) Model Numbers DYNJ69302, UDI/DI (EA)10193489926279, UDI/DI (CS)40193489926270; p) Model Numbers DYNJ69422, UDI/DI (EA)10193489937541, UDI/DI (CS)40193489937542; q) Model Numbers DYNJ69622, UDI/DI (EA)10193489959581, UDI/DI (CS)40193489959582; r) Model Numbers

UPC codes

10195327290979, 40195327290970, 10193489430721, 40193489430722, 10193489467840, 40193489467841, 10193489499179, 40193489499170, 10195327034054, 40195327034055, 10193489837315, 40193489837316, 10193489845402, 40193489845403, 10193489847727, 40193489847728, 10193489860375, 40193489860376, 10195327206840, 40195327206841, 10193489981360, 40193489981361, 10195327075569, 40195327075560, 10195327025717, 40195327025718, 10195327015800, 40195327015801, 10193489926279, 40193489926270, 10193489937541, 40193489937542, 10193489959581, 40193489959582, 10193489959567, 40193489959568, 10193489960693, 40193489960694, 10193489968927, 40193489968928

Source

Official record: FDA (Device enforcement) ↗

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