Recall Z-2106-2018— Datascope Corporation

Name: FDA recall Z-2106-2018
Creator: U.S. Food and Drug Administration
Published: 2016-03-11

Class III · Terminated

Class III FDA medical device recall by Datascope Corporation, initiated 2016-03-11, terminated 2019-06-07. It names one FDA 510(k) clearance: K080592. Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992. Reason: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE..

Recalling firm: Datascope Corporation
Classification: Class III
Status: Terminated
Initiated: 2016-03-11
Terminated: 2019-06-07
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080592 — HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AG·cleared 2008-09-11

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 Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Reason for recall

There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.

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