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) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725


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 CDS840214P, UDI/DI (EA) 10193489443196, UDI/DI (CS) 40193489443197; b) Model Number DYNJ82725, UDI/DI (EA) 10195327207380, UDI/DI (CS) 40195327207381
View official government recall

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