FDAClass IIIJune 13, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP recall

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

Why was Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch Number 3000020957, UDI Code 10607567203522

Product
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Recalling firm
Datascope Corporation
Quantity
194 total kits
Distribution
The products were distributed to the following US states: AL, OR, and TX.
Recall date
June 13, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls