Recall Z-1659-2023— Maquet Medical Systems USA

Name: FDA recall Z-1659-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-18

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2023-05-18. It names one FDA 510(k) clearance: K082117. Product: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829. Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2023-05-18
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K082117 — QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000Maquet Cardiopulmonary, AG·cleared 2009-02-18

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

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

Reason for recall

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

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