Recall Z-1129-2023— Access Vascular, Inc

Name: FDA recall Z-1129-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-16

Class II · Ongoing

Class II FDA medical device recall by Access Vascular, Inc, initiated 2022-12-16. It names one FDA 510(k) clearance: K203069. Product: HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002. Reason: 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..

Recalling firm: Access Vascular, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-12-16
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 - Basic Kit, Model Number 80004002

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.

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