MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C

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: 1240 units Lot/code info: All lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number SPEC0130C, UDI/DI (EA) 10193489196641, UDI/DI (CS) 20193489196648

UPC codes

10193489196641, 20193489196648

Source

Official record: FDA (Device enforcement) ↗

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