| Class 2 Device Recall Medtronic Adjustable valve | |
Date Initiated by Firm | August 27, 2008 |
Date Posted | September 30, 2008 |
Recall Status1 |
Terminated 3 on May 07, 2011 |
Recall Number | Z-2471-2008 |
Recall Event ID |
49433 |
510(K)Number | K052459 |
Product Classification |
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting - Product Code DTL
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Product | Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Medtronic delivery systems to reduce blood loss during percutaneous catheter procedures. It consists of an adjustable valve and flush port. |
Code Information |
Lot numbers: 33901607, 33907906, 33909207, 33913206, 33914207, 33917207, 33921308, 33925707, 33929306, 33931107, 33933205, 33934905, 33936105 |
Recalling Firm/ Manufacturer |
Medtronic Inc. Cardiac Rhythm Managment 8200 Coral Sea St Ne Mounds View MN 55112-4391
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For Additional Information Contact | 763-526-0000 |
Manufacturer Reason for Recall | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. |
FDA Determined Cause 2 | Process control |
Action | An Urgent Device Recall letter, dated August 28, 2008, was sent to affected consignees. The letter describes the issue, identifies affected product, and requests that affected product be removed from inventory and returned to Medtronic. Medtronic representatives with assist in returning unused valves and kits and provide replacements. Contact Medtronic at 1-763-526-0000 for assistance. |
Quantity in Commerce | 35,193 total |
Distribution | Worldwide Distribution --- including USA and except states OR, RI, and SD. Puerto Rico and Washington D.C. , and countries of Algeria , Argentina , Australia , Austria , Belgium , Bosnia And Herzegovina , Canada , Chile , Croatia , Czech Republic , Denmark , Egypt , Finland , France , Georgia , Germany , Greece , Guadeloupe , Hong Kong , Hungary , India , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Kuwait , Lithuania , Malta , Martinique , Morocco , Netherlands , Norway , Pakistan , Poland , Portugal , Puerto Rico ,Qatar , Reunion , Romania , Saudi Arabia , Slovakia , Slovenia , South Africa , Spain , Sri Lanka , Sweden , Switzerland , Syrian Arab Republic , Tunisia , Turkey , UK , Ukraine , United Arab Emirates , Uruguay , and Venezuela. |
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 = DTL
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