HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

FDA device recall Z-1605-2023 · posted 2023-05-18 · Open, Classified

Recall details

Recalling firm

Access Vascular, Inc

Reason for recall

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.

Action taken

An "Urgent Medical Device Correction" notification letter was sent to customers on 3/3/23. 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. 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.

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

LJS

Quantity affected

240 units

Distribution

US distribution to States of: FL, TN, TX.

Date initiated

2023-03-03

Date posted

2023-05-18

Location

Billerica, MA

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