Recall Z-1764-2022— Maquet Medical Systems USA

Name: FDA recall Z-1764-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-22

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2022-07-22. It names one FDA 510(k) clearance: K112360. Product: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.. Reason: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020)..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2022-07-22
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

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

Reason for recall

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

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