Recall Z-1373-2016— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-1373-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-23

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2016-02-23, terminated 2019-09-25. It names one FDA 510(k) clearance: K080470. Product: Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator. Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Terminated: 2019-09-25
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080470 — ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32Maquet Cardiopulmonary, AG·cleared 2008-09-12

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

Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

Reason for recall

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

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