Z-0490-2018Class II

Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal...

Name: Z-0490-2018 Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal...
Creator: Maquet
Published: 2017-05-22
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2017-05-22 / Terminated

FDA source

Maquet began a recall of Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures... on 2017-05-22. FDA classified it as Class II and gives the reason as "55 kits were distributed after their expiration date of September 2015". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0490-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-12-20
Terminated: 2018-07-12
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: 55 kits were distributed after their expiration date of September 2015.
FDA root cause: Incorrect or no expiration date
Action: Medical Device Recall (Removal) Notices were sent to customers via FedEx on 5/22/2017. The letters identified the affected device and the issue. Users are asked to examine their inventory to determine if any of the affected product is on hand. If found, affected devices should be removed and quarantined. Customers should contact Maquet/Getinge Customer Support at 1-888-627-8383 to obtain instructions on returning the affected devices. The Medical Device Recall Removal Response Form provided should be completed and returned. Questions should be directed to your Maquet/Getinge representative or call the Maquet/Getinge Customer Support at 1-888-627-8383.
Quantity in commerce: 55 units
Distribution: Distributed to the states of NM, CA, and IL.
Product codes and lots: Lot/batch number: 3000001571 UDI code: 607567206489

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0490-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0490-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-30

Product code DWE

K053025Class IIJostra Hlm Tubing SetMaquet Cardiopulmonary, AG / cleared 2005-11-10

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)