MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065

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: 3975 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DT22065, UDI/DI (EA) 10653160326601, UDI/DI (CS) 40653160326602

UPC codes

10653160326601, 40653160326602

Source

Official record: FDA (Device enforcement) ↗

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