CLASS III Device recall · Reported 13 Jun 2018 · FDA Enforcement Report

Maquet Cardiopulmonary Bypass Custom Tubing kit Beq-top recalled

Datascope is recalling Maquet Cardiopulmonary Bypass Custom Tubing kit Beq-top 15801 Neonatal Special, distributed in Alabama, Oregon, Texas. The recall was initiated on 11 Mar 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesBatch Number 3000020957, UDI Code 10607567203522

Quantity recalled194 total kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2105-2018
FDA event ID: 80086
Recalling firm: Datascope, Fairfield, NJ
Classification: Class III
Status: Terminated
Recall initiated: 11 Mar 2016
FDA classified: 6 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

11 Mar 2016	Recall initiated by company
6 Jun 2018	Classified by FDA	+817 days
13 Jun 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Alabama Oregon Texas

Questions about this recall

Why was it 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 lots are affected?

Batch Number 3000020957, UDI Code 10607567203522

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 80086

This product is part of a recall event; the main page for the event is Maquet Cardiopulmonary Bypass Custom Tubing kit Beq-top 5909 Qpid recalled.

Reported	Class	Recall	Company	Reason	Where
13 Jun 2018	CLASS III	Maquet Cardiopulmonary Bypass Custom Tubing kit Beq-top 5909 Qpid recalled	Datascope	Device Malfunction	AL, OR, TX
13 Jun 2018	CLASS III	Maquet Cardiopulmonary Bypass Custom Tubing kit Beq-t 5208 ECC SET recalled	Datascope	Device Malfunction	AL, OR, TX

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