Home / Recalls / Datascope Corporation / Z-2180-2018

Z-2180-2018 Class II Terminated

Recalled by Datascope Corporation — Fairfield, NJ

Recall Details

Product Type
Devices
Report Date
June 20, 2018
Initiation Date
July 27, 2017
Termination Date
February 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

UDI 0607567210004

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