Recall Z-1076-2024— Maquet Medical Systems USA

Name: FDA recall Z-1076-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-16

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2024-01-16. It names one FDA 510(k) clearance: K112360. Product: Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.. Reason: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2024-01-16
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

Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.

Reason for recall

The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

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