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) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;

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 CVI4510, UDI/DI (EA) 10653160321194, UDI/DI (CS) 00653160321197; b) Model Number STCVC01145B, UDI/DI (EA) 10653160351924, UDI/DI (CS) 00653160351927; c) Model Number STCVC2000, UDI/DI (EA) 10653160336792, UDI/DI (CS) 00653160336795

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