FDA recall Z-2105-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2016-03-11

Report date

2018-06-13

Termination date

2019-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2105-2018