Access Vascular, Inc recalls HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
- Recall date
- December 16, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1129-2023
- FDA classification
- Class II
- Brand / firm
- Access Vascular, Inc
- Sold / distributed
- US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
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