Class 2 Device Recall HydroMID 4Fr Single Lumen

• Date Initiated by Firm: December 16, 2022
• Date Posted: February 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1129-2023
• Recall Event ID: 91426
• 510(K)Number: K203069
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
• Code Information: UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226
• Recalling Firm/ Manufacturer: Access Vascular, Inc; 749 Middlesex Tpke; Billerica MA 01821-3906
• For Additional Information Contact: Brian Hanley; 781-538-6594
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Incorrect or no expiration date
• Action: Urgent Medical Device Correction notification letters were sent to customers beginning 12/16/22.. Access Vascular has identified that the catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. These catheters are individually packaged and supplied sterile along with a sterile kit. Our records indicate that your facility has received kits from the affected lots. We are contacting you to provide information on action to take to ensure patient safety. - Product that has already been used: No action required. The catheter and all kit components are currently within their expiration date, so no patient safety risk has been identified. - Product that has not been used: The catheter and all kit components are currently, within their expiration date, so no immediate patient safety risk has been identified. However, please refrain from using these kits as using the product used past its expiration date may contaminate the sterile field and result in an infection. AVI will provide a replacement label with the correct expiration date or replace the affected products. The following page identifies the shipments you have received with these impacted lots. 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. Access Vascular is committed to providing the highest quality products and support and is implementing corrective actions to prevent this issue from recurring in the future. We apologize for any inconvenience this may cause you and appreciate your understanding as we take steps to correct this issue. If you have any questions about this communication, please contact us at 781-538-6594.
• Quantity in Commerce: 1,789 HydroMID devices
• Distribution: US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
• 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 and Original Applicant = Access Vascular Inc.