HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 recallZ-1129-2023 · Access Vascular, Inc · initiated Dec 16, 2022

Why it was recalled

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 root cause category: Incorrect or no expiration date

What the company is doing

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.

Recall details

Recall number

Z-1129-2023

Status

Open, Classified

Initiated by the company

Dec 16, 2022

Posted by the FDA

Feb 10, 2023

Recalling firm

Access Vascular, Inc

Quantity

1,789 HydroMID devices

Product code

FOZ

FDA submissions

K203069

Distribution

US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.

Product description

HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• HydroMID Basic Kit 80004002

  Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
  1 recall0 reports

Other devices under the same FDA submission

2 devices cleared under K203069 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• HydroMID Maximal Barrier Kit 80004004

  Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
  2 recalls5 reports
• HydroMID MID-141

  Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
  4 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91426).

• Z-1130-2023 · Open, Classified
  HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
• Z-1131-2023 · Open, Classified
  HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001