Recall Z-0678-2020— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-0678-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-03

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2019-12-03, terminated 2020-09-18. It names one FDA 510(k) clearance: K991864. Product: Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.. Reason: A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2019-12-03
Terminated: 2020-09-18
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K991864 — ROTAFLOW CENTRIFUGAL PUMP SYSTEMJostra Medizintechnik AG·cleared 2000-08-31

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

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

Reason for recall

A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

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