Recall Z-0693-2020— Medtronic Perfusion Systems

Name: FDA recall Z-0693-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-14

Class II · Terminated

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2019-11-14, terminated 2020-10-05. It names one FDA 510(k) clearance: K952532. Product: Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351. Reason: Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Terminated
Initiated: 2019-11-14
Terminated: 2020-10-05
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K952532 — AFFINITY ARTERIAL BLOOD FILTERAvecor Cardiovascular, Inc.·cleared 1995-10-06

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

Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351

Reason for recall

Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

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