Z-0268-2016Class II

Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The...

Name: Z-0268-2016 Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The...
Creator: Medtronic Perfusion Systems
Published: 2015-10-28
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2015-10-28 / Terminated / root cause: packaging

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by... on 2015-10-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0268-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Posted: 2015-11-12
Terminated: 2016-08-17
Recalling firm: Medtronic Perfusion Systems
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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Medtronic sent an Urgent Medical Device Recall letter dated October 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were advised to quarantine and return all affected product and to complete and return the Customer Confirmation certificate. For questions contact your Medtronic representative or contact Medtronic's national Answering service at 800-633-8766.
Quantity in commerce: 496
Distribution: Nationwide Distribution including US: AL, IL, IN, and WI.
Product codes and lots: Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0268-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0268-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12

Product code DWF

K012538Class IITubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular / cleared 2001-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)