Recall Z-0839-2013— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-0839-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-26

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2012-12-26, terminated 2014-05-08. It names one FDA 510(k) clearance: K002857. Product: Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.. Reason: ELS 15 Fr Cannula could potentially contain an occluded arterial lumen..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2012-12-26
Terminated: 2014-05-08
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K002857 — ELS CANNULA (KIT), MODEL M1210-88,M1510-88Jostra AG·cleared 2000-10-05

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 ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.

Reason for recall

ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

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