MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472

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: 24192 units Lot/code info: All lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYND41472, UDI/DI (EA) 10080196996537, UDI/DI (CS) 40080196996538

UPC codes

10080196996537, 40080196996538

Source

Official record: FDA (Device enforcement) ↗

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