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Class 3 Device Recall Medtronic |
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Date Initiated by Firm |
October 01, 2007 |
Date Posted |
January 26, 2008 |
Recall Status1 |
Terminated 3 on October 23, 2008 |
Recall Number |
Z-0477-2008 |
Recall Event ID |
45485 |
510(K)Number |
K930154
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Product Classification |
Cardiopulmonary bypass blood reservoir. - Product Code DTN
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Product |
Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804 |
Code Information |
Lot Numbers 8763774, 8763791 and 8763782 (Model Number EL240) |
Recalling Firm/ Manufacturer |
Medtronic Perfusion Systems 7611 Northland Dr N Brooklyn Park MN 55428-1088
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For Additional Information Contact |
763-391-9000
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Manufacturer Reason for Recall |
Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Medtronic sales force was notified and initiated calls with cutomers on 10/1/07. Additionally, certified Urgent Medical Device Recall letters dated 10/5/2007, were sent to the 32 customers. The letter explained the situaiton and requested that the impacted product be returned for replacement or credit. Medtronic is assessing patient use risks and will report those when determined. Standard post-surgical monitoring is advised at the present by Medtronic . |
Quantity in Commerce |
413 |
Distribution |
Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DTN and Original Applicant = ELECTROMEDICS, INC.
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