medical Class II Updated 2023-07-26

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel,

Recalled Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A


Hazard / Issue

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4325, UDI/DI (EA) 10653160307037, UDI/DI (CS) 40653160307038; b) Model Number DT13351A, UDI/DI (EA) 10653160325581, UDI/DI (CS) 40653160325582
View official government recall

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