Datascope Corporation recalls Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maq…

Recall date

July 27, 2017

Source

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

Recall number

Z-2180-2018

FDA classification

Class II

Brand / firm

Datascope Corporation

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 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.