Datascope Corporation: Medical Device Recall in 2018 - (Recall #: Z-2178-2018)

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 BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.

Product Classification:

Class II

Date Initiated: July 27, 2017

Date Posted: June 20, 2018

Recall Number: Z-2178-2018

Event ID: 80081

Reason for Recall:

There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.

Status: Terminated

Product Quantity: 10

Code Information:

UDI 0607567204133

Distribution Pattern:

The products were distributed to the following US states: IA and FL.

Voluntary or Mandated:

Voluntary: Firm initiated