PlainRecalls
FDA Devices Low Class III Terminated

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Reported: June 13, 2018 Initiated: March 11, 2016 #Z-2106-2018

Product Description

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

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.

Details

Recalling Firm
Datascope Corporation
Units Affected
19 total kits
Distribution
The products were distributed to the following US states: AL, OR, and TX.
Location
Fairfield, NJ

Frequently Asked Questions

What product was recalled?
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992. Recalled by Datascope Corporation. Units affected: 19 total kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 13, 2018. Severity: Low. Recall number: Z-2106-2018.