Recall Z-2765-2017— Medtronic Perfusion Systems

Name: FDA recall Z-2765-2017
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: K900994. Product: DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae. 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

K900994 — ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.Dlp, Inc.·cleared 1990-08-15

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 Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae

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.