Z-2180-2018Class II

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01

Name: Z-2180-2018 Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01
Creator: Datascope Corporation
Published: 2017-07-27
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-07-27 / Terminated / root cause: manufacturing process

FDA source

Datascope Corporation began a recall of Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing... on 2017-07-27. FDA classified it as Class II and gives the reason as "There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2180-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-27
Posted: 2018-10-11
Terminated: 2020-02-07
Recalling firm: Datascope Corp.
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 7/27/17, an Urgent Safety Alert was issued to customers of the Cardiovascular Procedure Kit with LN130B Over-pressure Safety Valves. The safety alert instructed customers to perform the following: Please examine your inventory immediately to determine if you have unused kits of the batch numbers listed. If so, please follow the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. It is possible that custom tubing kits with the affected valves may have already been used without issue. Customers were instructed to test the valve prior to use. The notice was sent to customers again on 10/3/17 and 12/12/17. On 1/11/18, Urgent Medical Device Recall letters were sent to customers. The letters included the following instructions: Terumo CVS now recommends removal of any remaining product from your inventory. A review of our records indicates that you have received the following Maquet/Getinge Custom Tubing Kit batch numbers affected by the Terumo Cardiovascular Systems Medical Device Recall (refer to information provided in the table below). Please examine your inventory immediately to determine if you have unused custom tubing kits of the batch numbers listed. If so, please remove the affected products, quarantine them and follow the instructions for returning the product to Maquet/Getinge for full credit. It is possible that custom tubing kits with the affected valves may have already been used without issue. The Terumo Cardiovascular Systems Medical Device Recall affects the Custom Tubing Kit with LN130B Over-pressure Safety Valve distributed by Maquet/Getinge having lot/batch numbers listed above; no other product lot/batch numbers that were delivered to you are affected. Instructions for returning affected product: 1. Review this notice and Terumos Medical Device Recall Notice (attached). 2. Ensure that all users (i.e. perfusionist, operating room staff and biomedical staff) receive notice
Quantity in commerce: 8
Distribution: The products were distributed to the following US states: IA and FL.
Product codes and lots: UDI 0607567210004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2180-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2178-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-13
Z-2179-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-13
Z-2180-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)