FDA-Device2023-02-22Class II
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Access Vascular, Inc
Hazard
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Sold states
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Affected count
1,789 HydroMID devices
Manufactured in
749 Middlesex Tpke, N/A, Billerica, MA, United States
Products
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1129-2023Don't want to check this manually?
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