Recall Z-2495-2020— Medtronic Perfusion Systems

Name: FDA recall Z-2495-2020
Creator: U.S. Food and Drug Administration
Published: 2018-08-08

Class II · Terminated

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2018-08-08, terminated 2020-10-06. It names one FDA 510(k) clearance: K891687. Product: Extra corporeal circuit with bio-active surface.. Reason: Affected products failed a sterilization test..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Terminated: 2020-10-06
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMedtronic Blood Systems, Inc.·cleared 1989-05-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Extra corporeal circuit with bio-active surface.

Reason for recall

Affected products failed a sterilization test.

Data sourced from openFDA. This site is unofficial and independent of the FDA.