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U.S. Department of Health and Human Services

Class 2 Device Recall Perfusion tubing Set

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  Class 2 Device Recall Perfusion tubing Set see related information
Date Initiated by Firm October 28, 2015
Create Date November 12, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-0268-2016
Recall Event ID 72550
510(K)Number K012538  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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.
Code Information Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346,  209704347,210010558    TL7M64R3 209789393 TL7P17R1 209789333
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Representative
800-633-8766
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC VASCULAR
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