Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490

Recall date

March 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2105-2018

FDA classification

Class III

Brand / firm

Datascope Corporation

Sold / distributed

The products were distributed to the following US states: AL, OR, and TX.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490