Recall Z-1874-2021— Medtronic Perfusion Systems

Name: FDA recall Z-1874-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-29

Class II · Terminated

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2021-04-29, terminated 2023-03-20. It names one FDA 510(k) clearance: K171979. Product: Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.. Reason: Specific lots may have been manufactured with insufficient or incomplete welds..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Terminated
Initiated: 2021-04-29
Terminated: 2023-03-20
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K171979 — Tubing PackMedtronic, Inc.·cleared 2017-10-27

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 BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.

Reason for recall

Specific lots may have been manufactured with insufficient or incomplete welds.

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