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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Implantable Programmable Infusion Pumps

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  Class 2 Device Recall Medtronic Implantable Programmable Infusion Pumps see related information
Date Initiated by Firm April 04, 2014
Date Posted May 08, 2014
Recall Status1 Terminated 3 on November 05, 2014
Recall Number Z-1568-2014
Recall Event ID 68031
PMA Number P860004S056 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps.

Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
Code Information Lot numbers CS3643, CS3613, CS3663, N441998, N442081, N442131, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N442178, N442513, N442532, N442560, N442588, N442831, and N443427. Affected lots were distributed between January 2014 and March 2014.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Neuromodulation Technical Serv
800-707-0933
Manufacturer Reason
for Recall		 Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
FDA Determined
Cause 2		 Process control
Action Medtronic sent a "Medical Device Removal" letter dated April 2014 hand delivered, e-mail or faxed to affected customers. The letter described the problem and the product affected by the recall. The letter also contained the Action Required, Additional Information (Contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm Central Time) and requested consignees to complete and fax or e-mail the "Medical Device Removal Reply Form".
Quantity in Commerce 13,784
Distribution Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
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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