FDA-Device2023-07-26Class II
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K
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
4644 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) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2176-2023Don't want to check this manually?
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