Recall Z-2160-2018— Maquet Cardiopulmonary Ag

Name: FDA recall Z-2160-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-14

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiopulmonary Ag, initiated 2018-05-14, terminated 2020-05-15. It names one FDA 510(k) clearance: K012774. Product: Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass. Reason: This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula..

Recalling firm: Maquet Cardiopulmonary Ag
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Terminated: 2020-05-15
Firm location: Rastatt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K012774 — JOSTRA ARTERIAL PERFUSION CANNULAEJostra AG·cleared 2001-11-16

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

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass

Reason for recall

This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

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