MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ647

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 Number DYNJ64675, UDI/DI (EA) 10193489212143,UDI/DI (CS) 40193489212144; b) Model Number DYNJ64725B, UDI/DI (EA) 10193489452846,UDI/DI (CS) 40193489452847; c) Model Number DYNJ65560C, UDI/DI (EA) 10195327136819,UDI/DI (CS) 40195327136810; d) Model Number DYNJ65775, UDI/DI (EA) 10193489289824,UDI/DI (CS) 40193489289825; e) Model Number DYNJ65827, UDI/DI (EA) 10193489298499,UDI/DI (CS) 40193489298490; f) Model Number DYNJ65838, UDI/DI (EA) 10193489303261,UDI/DI (CS) 40193489303262; g) Model Number DYNJ66062, UDI/DI (EA) 10193489319217,UDI/DI (CS) 40193489319218; h) Model Number DYNJ66259, UDI/DI (EA) 10193489325485,UDI/DI (CS) 40193489325486; i) Model Number DYNJ66271B, UDI/DI (EA) 10193489998917,UDI/DI (CS) 40193489998918; j) Model Number DYNJ66271D, UDI/DI (EA) 10195327130749,UDI/DI (CS) 40195327130740; k) Model Number DYNJ66356F, UDI/DI (EA) 10195327160012,UDI/DI (CS) 40195327160013; l) Model Number DYNJ66499A, UDI/DI (EA) 10193489977523,UDI/DI (CS) 40193489977524; m) Model Number DYNJ66499B, UDI/DI (EA) 10195327242107,UDI/DI (CS) 40195327242108; n) Model Number DYNJ66743B, UDI/DI (EA) 10193489949797,UDI/DI (CS) 40193489949798; o) Model Number DYNJ66916, UDI/DI (EA) 10193489387650,UDI/DI (CS) 40193489387651; p) Model Number DYNJ67115A, UDI/DI (EA) 10195327091880,UDI/DI (CS) 40195327091881; q) Model Number DYNJ67415, UDI/DI (EA) 10193489930887,UDI/DI (CS) 40193489930888; r) Model Numbe

UPC codes

10193489212143, 40193489212144, 10193489452846, 40193489452847, 10195327136819, 40195327136810, 10193489289824, 40193489289825, 10193489298499, 40193489298490, 10193489303261, 40193489303262, 10193489319217, 40193489319218, 10193489325485, 40193489325486, 10193489998917, 40193489998918, 10195327130749, 40195327130740, 10195327160012, 40195327160013, 10193489977523, 40193489977524, 10195327242107, 40195327242108, 10193489949797, 40193489949798, 10193489387650, 40193489387651, 10195327091880, 40195327091881, 10193489930887, 40193489930888, 10193489409321, 40193489409322, 10193489421675, 40193489421676, 10195327331719, 40195327331710

Source

Official record: FDA (Device enforcement) ↗

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