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) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B

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 CDS840215O, UDI/DI (EA) 10193489448993, UDI/DI (CS) 40193489448994; b) Model Number DYNDH1187A, UDI/DI (EA) 10889942702633, UDI/DI (CS) 40889942702634; c) Model Number DYNJ906905B, UDI/DI (EA) 10193489884944, UDI/DI (CS) 40193489884945;
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