Recall Z-1336-2023— Maquet Cardiovascular, LLC

Name: FDA recall Z-1336-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-06

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-03-06. It names one FDA 510(k) clearance: K101274. Product: VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000. Reason: Some batches of product were not sterilized to their minimum sterilization specification..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-03-06
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K101274 — VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEMMaquet Cardiovascular, LLC·cleared 2010-06-11

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

VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

Reason for recall

Some batches of product were not sterilized to their minimum sterilization specification.

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