Recall Z-2140-2021— Maquet Medical Systems USA

Name: FDA recall Z-2140-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-14

Class II · Terminated

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2021-07-14, terminated 2022-08-03. It names one FDA 510(k) clearance: K031544. Product: Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.. Reason: There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Terminated
Initiated: 2021-07-14
Terminated: 2022-08-03
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K031544 — HEATER COOLER UNIT, MODEL HCU 30Jostra AB·cleared 2003-08-07

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

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

Reason for recall

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

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