Recall Z-0632-2021— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-0632-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-20

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2020-11-20, terminated 2024-11-07. It names one FDA 510(k) clearance: K112360. Product: HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.. Reason: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2020-11-20
Terminated: 2024-11-07
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K112360 — QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIESMaquet Cardiopulmonary, AG·cleared 2011-09-15

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

HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

Reason for recall

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

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