Access Vascular, Inc 2023-03-01 Health serious FDA
Health · FDA · Recall #FDA-Z-1155-2023
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access… Recall
Issued March 1, 2023 · Access Vascular, Inc
In March 2023, Access Vascular, Inc recalled the HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Product Mislabeled on the outer bag and inner kit Tyvek header bag
What you should do
- 1 Stop using HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Access Vascular, Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Access Vascular, Inc
- Category
- Health
- Recall date
- March 1, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of FL, TX, WA.
- Recall number
- FDA-Z-1155-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Access Vascular, Inc has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.