Reported Feb 22, 2023 · Ongoing
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Access Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Access Vascular, Inc · 749 Middlesex Tpke · Billerica, MA · 01821-3906
Is this the product you have?
HydroMID 4Fr Single Lumen - Basic KitModel Number 80004002
- Lot codes and dates
- UDI-DI(01)00850030354006
- Lot Number
114283611139326011395226
- Amount recalled
- 1,789 HydroMID devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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