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U.S. Department of Health and Human Services

Class 2 Device Recall 8596SC Intrathecal Catheter Pump Segment Revision Kit

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  Class 2 Device Recall 8596SC Intrathecal Catheter Pump Segment Revision Kit see related information
Date Initiated by Firm January 09, 2008
Date Posted July 22, 2008
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-1308-2008
Recall Event ID 46814
PMA Number P860004S081 
Product Classification Programmable implanted infusion pump - Product Code LKK
Product Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC.
Code Information Lot Numbers: N131154001, N131154003, N131154004, N131154008, N131154009, N131154010, N131154013, N131154016, N131154017, N130483001, N130483004, N130483006, N130483011, N130483012, N130483013, N130483014, N130483015 and N130483021.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified by an Urgent Medical Device Recall letter sent in January 2008. The letter informed users that the recalling firm would contact them regarding removing the affected products from their inventory. Users were requested to return a response form indicating the number of affected product. For additional information, contact 1-800-707-0933.
Quantity in Commerce 18
Distribution Nationwide Distribution including states of MI, OR, IN, NY, FL, PA, MN, TX, CO and UT.
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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