HydroMID 4Fr Single Lumen - Basic Kit recall
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Why was HydroMID 4Fr Single Lumen - Basic Kit 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.
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-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226
- Product
- HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
- Recalling firm
- Access Vascular, Inc
- Quantity
- 1,789 HydroMID devices
- Distribution
- US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
- Recall date
- February 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)