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U.S. Department of Health and Human Services

Class 3 Device Recall Intersept Custom Tubing Pack

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 Class 3 Recall
Intersept Custom Tubing Pack
see related information
Date Posted March 08, 2007
Recall Status1 Terminated on February 24, 2008
Recall Number Z-0583-2007
Recall Event ID 37079
Premarket Notification
510(K) Numbers
K800178  K891687 
Product Classification Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
Product Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.
Code Information Lot 5666215
Recalling Firm/
Manufacturer
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park, Minnesota 55428-1088
Manufacturer Reason
for Recall
One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
FDA Determined
Cause 2
DESIGN: Device Design
Action There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.
Quantity in Commerce 17
Distribution Illinois
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWE and Original Applicant = EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
510(K)s with Product Code = DWE and Original Applicant = MEDTRONIC BLOOD SYSTEMS, INC.
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