Recall Z-1156-2023— Access Vascular, Inc

Name: FDA recall Z-1156-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-22

Class II · Ongoing

Class II FDA medical device recall by Access Vascular, Inc, initiated 2022-12-22. It names one FDA 510(k) clearance: K203069. Product: HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004. Reason: Label with the incorrect component listed on the inner kit Tyvek header bag.

Recalling firm: Access Vascular, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-12-22
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K203069 — HydroMIDAccess Vascular, Inc.·cleared 2021-02-08

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

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

Reason for recall

Label with the incorrect component listed on the inner kit Tyvek header bag

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