Date Initiated by Firm | July 23, 2004 |
Date Posted | August 24, 2004 |
Recall Status1 |
Terminated 3 on November 23, 2005 |
Recall Number | Z-1384-04 |
Recall Event ID |
29663 |
PMA Number | P860004 |
Product Classification |
Pump, Infusion, Implanted, Programmable - Product Code LKK
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Product | The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK. |
Code Information |
CS0293 |
Recalling Firm/ Manufacturer |
Medtronic Inc, Neurological & Spinal Division 800 53rd Ave Ne Columbia Heights MN 55421-1241
|
For Additional Information Contact | Michelle Reinert 763-505-0203 |
Manufacturer Reason for Recall | The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293. |
FDA Determined Cause 2 | Other |
Action | The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of manufactured product: CS0293. |
Quantity in Commerce | 405 kits |
Distribution | US and one customer in New Zealand. |
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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PMA Database | PMAs with Product Code = LKK
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