Z-2495-2020Class II

Extra corporeal circuit with bio-active surface

Name: Z-2495-2020 Extra corporeal circuit with bio-active surface
Creator: Medtronic Perfusion Systems
Published: 2018-08-08
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2018-08-08 / Terminated / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of Extra corporeal circuit with bio-active surface on 2018-08-08. FDA classified it as Class II and gives the reason as "Affected products failed a sterilization test". 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-2495-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Posted: 2020-07-04
Terminated: 2020-10-06
Recalling firm: Medtronic Perfusion Systems
Product: Extra corporeal circuit with bio-active surface.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Affected products failed a sterilization test.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On August 8th Medtronic vervally communicated to the consignees to informed them about the situation and affected product. On August 20th they send a letter to the consignees stating that "as a result of the immediate verbal communication, your Medtronic representative has already retrieved the affected product from your facility. This notification is for your awareness and Medtronic requests that you complete and return the attached Customer Confirmation Certificate to [email protected]."
Quantity in commerce: 10 units
Distribution: Domestic Distribution only to CA and MI.
Product codes and lots: Lot# 215729283

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2495-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2495-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code DTZ

K891687Class IIExtracorporeal Circuit with Bio-Active SurfaceMedtronic Blood Systems, Inc. / cleared 1989-05-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)