Medtronic Perfusion Systems: Medical Device Recall in 2015 - (Recall #: Z-0268-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 28, 2015

Date Posted: November 18, 2015

Recall Number: Z-0268-2016

Event ID: 72550

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.

Status: Terminated

Product Quantity: 496

Code Information:

Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333

Distribution Pattern:

Nationwide Distribution including US: AL, IL, IN, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated