MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A

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: 2304 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DYNJ69864A, UDI/DI (EA) 10195327132057, UDI/DI (CS) 40195327132058

UPC codes

10195327132057, 40195327132058

Source

Official record: FDA (Device enforcement) ↗

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