MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model

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: 4148 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS840215O, UDI/DI (EA) 10193489448993, UDI/DI (CS) 40193489448994; b) Model Number DYNDH1187A, UDI/DI (EA) 10889942702633, UDI/DI (CS) 40889942702634; c) Model Number DYNJ906905B, UDI/DI (EA) 10193489884944, UDI/DI (CS) 40193489884945;

UPC codes

10193489448993, 40193489448994, 10889942702633, 40889942702634, 10193489884944, 40193489884945

Source

Official record: FDA (Device enforcement) ↗

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