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) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464;

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 CVI4770A, UDI/DI (EA) 10653160350828, UDI/DI (CS) 00653160350821; b) Model Number DT21275, UDI/DI (EA) 10653160318934, UDI/DI (CS) 00653160318937; c) Model Number EBSI1382, UDI/DI (EA) 10193489196269, UDI/DI (CS) 20193489196266; d) Model Number EBSI1464, UDI/DI (EA) 10193489198959, UDI/DI (CS) 20193489198956;

View official government recall

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