Datascope Corporation: Medical Device Recall in 2018 - (Recall #: Z-2105-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: March 11, 2016

Date Posted: June 13, 2018

Recall Number: Z-2105-2018

Event ID: 80086

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.

Status: Terminated

Product Quantity: 194 total kits

Code Information:

Batch Number 3000020957, UDI Code 10607567203522

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated