HydroMID 4Fr Single Lumen Maximal Barrier Kit recall: Labeling Error
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous…
Why was HydroMID 4Fr Single Lumen Maximal Barrier Kit recalled?
Product Mislabeled on the outer bag and inner kit Tyvek header bag
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)00850030354020 Lot Number: 11434018
- Product
- HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous…
- Recalling firm
- Access Vascular, Inc
- Quantity
- 155 units
- Distribution
- US Nationwide distribution in the states of FL, TX, WA.
- Recall date
- March 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)