MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N

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: 78 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNJ902540N, UDI/DI (EA) 10193489916669, UDI/DI (CS) 40193489916660

UPC codes

10193489916669, 40193489916660

Source

Official record: FDA (Device enforcement) ↗

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