HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access

FDA device recall Z-1156-2023 · posted 2023-02-22 · Open, Classified

Recall details

Recalling firm

Access Vascular, Inc

Reason for recall

Label with the incorrect component listed on the inner kit Tyvek header bag

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FOZ

Quantity affected

445 units

Distribution

US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.

Date initiated

2022-12-22

Date posted

2023-02-22

Location

Billerica, MA

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