Recall Z-1605-2023— Access Vascular, Inc

Name: FDA recall Z-1605-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-03

Class II · Ongoing

Class II FDA medical device recall by Access Vascular, Inc, initiated 2023-03-03. It names one FDA 510(k) clearance: K193015. Product: HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004. Reason: 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..

Recalling firm: Access Vascular, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-03-03
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193015 — HydroPICC (PICC-142)Access Vascular, Inc.·cleared 2020-02-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.