Recall Z-3128-2024— Medtronic Perfusion Systems

Name: FDA recall Z-3128-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-09

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-07-09. It names one FDA 510(k) clearance: K120988. Product: Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312. Reason: During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312)..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2024-07-09
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K120988 — DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHTMedtronic, Inc.·cleared 2012-07-25

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 DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

Reason for recall

During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

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