MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VAS

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: 172722 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 May 2023: a) Model Number 00-401185Q, UDI/DI (EA) 10193489489088, UDI/DI (CS)40193489489089; b) Model Number CDS840487I, UDI/DI (EA) 10193489445343, UDI/DI (CS)40193489445344; c) Model Number CDS983147I, UDI/DI (EA) 10195327075514, UDI/DI (CS)40195327075515; d) Model Number CDS983394I, UDI/DI (EA) 10193489819953, UDI/DI (CS)40193489819954; e) Model Number CDS983394J, UDI/DI (EA) 10195327069872, UDI/DI (CS)40195327069873; f) Model Number CDS983394K, UDI/DI (EA) 10195327292584, UDI/DI (CS)40195327292585; g) Model Number CDS983513F, UDI/DI (EA) 10193489843729, UDI/DI (CS)40193489843720; h) Model Number CDS983849D, UDI/DI (EA) 10193489278231, UDI/DI (CS)40193489278232; i) Model Number CDS983849F, UDI/DI (EA) 10195327228316, UDI/DI (CS)40195327228317; j) Model Number CDS984292I, UDI/DI (EA) 10193489862485, UDI/DI (CS)40193489862486; k) Model Number CDS984355G, UDI/DI (EA) 10193489484632, UDI/DI (CS)40193489484633; l) Model Number CDS984642, UDI/DI (EA) 10884389882924, UDI/DI (CS)40884389882925; m) Model Number CDS984764G, UDI/DI (EA) 10193489450293, UDI/DI (CS)40193489450294; n) Model Number CDS985105O, UDI/DI (EA) 10195327036249, UDI/DI (CS)40195327036240; o) Model Number CDS985355D, UDI/DI (EA) 10193489442779, UDI/DI (CS)40193489442770; p) Model Number CDS985355F, UDI/DI (EA) 10195327242626, UDI/DI (CS)40195327242627; q) Model Number CVI4955, UDI/DI (EA) 10195327325848, UDI/DI (CS)40195327325849; r) Model Num

UPC codes

10193489489088, 40193489489089, 10193489445343, 40193489445344, 10195327075514, 40195327075515, 10193489819953, 40193489819954, 10195327069872, 40195327069873, 10195327292584, 40195327292585, 10193489843729, 40193489843720, 10193489278231, 40193489278232, 10195327228316, 40195327228317, 10193489862485, 40193489862486, 10193489484632, 40193489484633, 10884389882924, 40884389882925, 10193489450293, 40193489450294, 10195327036249, 40195327036240, 10193489442779, 40193489442770, 10195327242626, 40195327242627, 10195327325848, 40195327325849, 10193489478693, 40193489478694, 10193489191790, 40193489191791, 10193489493603, 40193489493604

Source

Official record: FDA (Device enforcement) ↗

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