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U.S. Department of Health and Human Services

Class 2 Device Recall The Model 8540 Catheter Access Port Kit

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 Class 2 Device Recall The Model 8540 Catheter Access Port Kitsee related information
Date Initiated by FirmJuly 23, 2004
Date PostedAugust 24, 2004
Recall Status1 Terminated 3 on November 23, 2005
Recall NumberZ-1384-04
Recall Event ID 29663
PMA NumberP860004 
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
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 ContactMichelle 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
ActionThe 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 Commerce405 kits
DistributionUS and one customer in New Zealand.
Total Product Life CycleTPLC 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.
PMA DatabasePMAs with Product Code = LKK
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