MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number D

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: 4644 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ46967F, UDI/DI (EA) 10193489576047UDI/DI (CS) 40193489576048; b) Model Number DYNJ62557, UDI/DI (EA) 10193489669152UDI/DI (CS) 40193489669153; c) Model Number DYNJ81973, UDI/DI (EA) 10195327204877UDI/DI (CS) 40195327204878; d) Model Number TVS4000K, UDI/DI (EA) 10816982023862UDI/DI (CS) 40816982023863;

UPC codes

40193489576048, 40193489669153, 40195327204878, 40816982023863

Source

Official record: FDA (Device enforcement) ↗

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