MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F

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: 1130 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number OST011F, UDI/DI (EA) 10195327091347, UDI/DI (CS) 40195327091348

UPC codes

10195327091347, 40195327091348

Source

Official record: FDA (Device enforcement) ↗

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