—#141501

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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K012538
Affected lot / code info: Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

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

Timeline

Recall initiated: 2015-10-28
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141501. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.