Z-2105-2018Class III

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

Name: Z-2105-2018 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Creator: Datascope Corporation
Published: 2016-03-11
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2016-03-11 / Terminated

FDA source

Datascope Corporation began a recall of Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490 on 2016-03-11. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2105-2018
Classification: Class III
Status: Terminated
Initiated: 2016-03-11
Posted: 2018-06-06
Terminated: 2019-06-07
Recalling firm: Datascope Corp.
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
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.
FDA root cause: Under Investigation by firm
Action: Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via email to [email protected].
Quantity in commerce: 194 total kits
Distribution: The products were distributed to the following US states: AL, OR, and TX.
Product codes and lots: Batch Number 3000020957, UDI Code 10607567203522

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2105-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2104-2018	Class III	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-06
Z-2105-2018	Class III	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-06
Z-2106-2018	Class III	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-06

Product code DWE

K080592Class IIHlm Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG / cleared 2008-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)