FDAClass IIJune 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T recall

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass…

Why was Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T recalled?

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

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?

UDI 0607567203600

Product
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass…
Recalling firm
Datascope Corporation
Quantity
27
Distribution
The products were distributed to the following US states: IA and FL.
Recall date
June 20, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls