HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
- Company
- Access Vascular, Inc
- Recall Initiated
- December 16, 2022
- Posted
- February 10, 2023
- Recall Number
- Z-1129-2023
- Quantity
- 1,789 HydroMID devices
- Firm Location
- Billerica, MA
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.
Distribution
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Lot / Code Info
UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226
Root Cause
Incorrect or no expiration date
Action Taken
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.