FDA-Device2023-07-26Class II
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;
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Sold states
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Affected count
620 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2195-2023Don't want to check this manually?
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