Class 2 Device Recall HydroMID 4F Single Lumen Midline Catheter

• Date Initiated by Firm: December 22, 2022
• Date Posted: February 22, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1156-2023
• Recall Event ID: 91533
• 510(K)Number: K203069
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• 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
• Code Information: UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076
• Recalling Firm/ Manufacturer: Access Vascular, Inc; 749 Middlesex Tpke; Billerica MA 01821-3906
• For Additional Information Contact: SAME; 781-538-6594
• Manufacturer Reason for Recall: Label with the incorrect component listed on the inner kit Tyvek header bag
• FDA Determined 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 in Commerce: 445 units
• Distribution: US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FOZ