MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model N

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: 1380 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4325, UDI/DI (EA) 10653160307037, UDI/DI (CS) 40653160307038; b) Model Number DT13351A, UDI/DI (EA) 10653160325581, UDI/DI (CS) 40653160325582

UPC codes

10653160307037, 40653160307038, 10653160325581, 40653160325582

Source

Official record: FDA (Device enforcement) ↗

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