FDA Medical Device Recalls (openFDA)
Access Vascular, Inc: HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
- Recall number
- Z-1156-2023
- Recalling firm
- Access Vascular, Inc
- Product
- HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
- Status
- Open, Classified
- Initiated
- 2022-12-22
- Posted
- 2023-02-22
- Terminated
- not on file
- Reason
- Label with the incorrect component listed on the inner kit Tyvek header bag
- Root cause
- Under Investigation by firm
- Action
- Access Vascular issued Urgent Medical Device Correction-HydroMID Labeling on 12/22/22. Letter states reason for recall, health risk and action to take: Product that has already been used: No action required. There is no patient safety risk has been identified. - Product that has not been used: The kit labeling identified components which are not included in the kit, however there is no immediate patient safety risk. However, please refrain from using these kits as additional kit components may be required may cause an inconvenient in completing the procedure. AVI will provide a replacement label with the correct contents or replace the product. Please forward this notice in the event the affected product was further distributed. We will contact you to identify the number of kits that are currently in your inventory and determine the appropriate correction with your input, in a timely manner. If you have any questions about this communication, please contact us at 781-538-6594.
- Quantity
- 445 units
- Distribution
- US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
- Lot, serial or model codes
- UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076
- 510(k) numbers
- ["K203069"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3021570645
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28