MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART

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: 39391 units Lot/code info: All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART1005, UDI/DI (EA) 10193489198232, UDI/DI (CS) 20193489198239; b) Model Number ART1165, UDI/DI (EA) 10653160354680, UDI/DI (CS) 00653160354683; c) Model Number ART240A, UDI/DI (EA) 10653160328025, UDI/DI (CS) 00653160328028; d) Model Number ART245A, UDI/DI (EA) 10653160328018, UDI/DI (CS) 00653160328011; e) Model Number ART245B, UDI/DI (EA) 10653160358442, UDI/DI (CS) 00653160358445; f) Model Number ART255, UDI/DI (EA) 10653160311997, UDI/DI (CS) 00653160311990; g) Model Number ART560, UDI/DI (EA) 10653160310822, UDI/DI (CS) 00653160310825; h) Model Number ART690, UDI/DI (EA) 10653160318019, UDI/DI (CS) 00653160318012; i) Model Number ART840, UDI/DI (EA) 10653160322924, UDI/DI (CS) 00653160322927; j) Model Number ART960, UDI/DI (EA) 10193489190915, UDI/DI (CS) 20193489190912; k) Model Number ART970, UDI/DI (EA) 10193489190922, UDI/DI (CS) 20193489190929; l) Model Number BT235A, UDI/DI (EA) 10653160315919, UDI/DI (CS) 00653160315912; m) Model Number CHT1825, UDI/DI (EA) 10653160328988, UDI/DI (CS) 00653160328981; n) Model Number CVI3735, UDI/DI (EA) 10653160261544, UDI/DI (CS) 00653160261547; o) Model Number CVI4025A, UDI/DI (EA) 10193489396058, UDI/DI (CS) 40193489396059; p) Model Number CVI4180, UDI/DI (EA) 10653160284451, UDI/DI (CS) 00653160284454; q) Model Number CVI4265, UDI/DI (EA) 10653160291268, UDI/DI (CS) 00653160291261; r) Model Number CVI4430, UDI/DI (EA) 106531603

UPC codes

10193489198232, 20193489198239, 10653160354680, 00653160354683, 10653160328025, 00653160328028, 10653160328018, 00653160328011, 10653160358442, 00653160358445, 10653160311997, 00653160311990, 10653160310822, 00653160310825, 10653160318019, 00653160318012, 10653160322924, 00653160322927, 10193489190915, 20193489190912, 10193489190922, 20193489190929, 10653160315919, 00653160315912, 10653160328988, 00653160328981, 10653160261544, 00653160261547, 10193489396058, 40193489396059, 10653160284451, 00653160284454, 10653160291268, 00653160291261, 10653160314370, 00653160314373, 10653160320517, 00653160320510, 10653160319047, 00653160319040

Source

Official record: FDA (Device enforcement) ↗

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