Home / Recalls / Medical Devices
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABS
Recalled July 26, 2023 · FDA recall Z-2175-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. · FDA Class II
Units
2739 units
Sold at
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Description
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION KIT, Model Number ECVC1655; e) CVC INSERTION ACCESSORY KIT, Model Number ECVC7880; f) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635B
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →