MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures

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: 1,505,262 kits Lot/code info: All lots within expiry, distributed from Medline between December 2017 May 2023: Model Number (GTIN Number): DYNJE5900 (Each: 10884389114124, Case: 40884389114125), DYNJE5910 (Each: 10884389114094, Case: 40884389114095), DYNJE5920 (Each: 10884389114100, Case: 40884389114101), DYNJE5930 (Each: 10884389114117, Case: 40884389114118), DYNJE5940 (Each: 10888277723641, Case: 20888277723648), DYNJEX5900 (Each: 10884389114124, Case: 40884389114125). All lots within their expiration date.

UPC codes

10884389114124, 40884389114125, 10884389114094, 40884389114095, 10884389114100, 40884389114101, 10884389114117, 40884389114118, 10888277723641, 20888277723648

Source

Official record: FDA (Device enforcement) ↗

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