MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS 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: 575 units Lot/code info: All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1112, UDI/DI (EA) 10889942277360, UDI/DI (CS) 40889942277361; b) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509; c) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836

UPC codes

10889942277360, 40889942277361, 10889942611508, 40889942611509, 10889942519835, 40889942519836

Source

Official record: FDA (Device enforcement) ↗

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