Recall Z-2767-2017— Medtronic Perfusion Systems

Name: FDA recall Z-2767-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-22

Class II · Terminated

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2017-06-22, terminated 2020-07-22. It names one FDA 510(k) clearance: K831591. Product: DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.. Reason: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Terminated
Initiated: 2017-06-22
Terminated: 2020-07-22
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K831591 — AORTIC ROOT CANNULA W/INTEGRAL PRESSDlp, Inc.·cleared 1983-06-30

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

DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

Reason for recall

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

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