Recall Z-0268-2016— Medtronic Perfusion Systems

Name: FDA recall Z-0268-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-28

Class II · Terminated

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2015-10-28, terminated 2016-08-17. It names one FDA 510(k) clearance: K012538. Product: Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.. Reason: This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Terminated: 2016-08-17
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K012538 — TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACEMedtronic Vascular·cleared 2001-08-23

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 Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.

Reason for recall

This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.

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