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U.S. Department of Health and Human Services

Class 2 Device Recall Synchromed II

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  Class 2 Device Recall Synchromed II see related information
Date Initiated by Firm May 11, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 23, 2005
Recall Number Z-1040-04
Recall Event ID 29297
PMA Number P860004/060 
Product Classification Pump, Infusion - Product Code FRN
Product Synchromed II infusion pump
Code Information Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N
Recalling Firm/
Manufacturer		 Medtronic Inc, Neurological & Spinal Division
800 53rd Ave Ne
Columbia Heights MN 55421-1241
Manufacturer Reason
for Recall		 The opposite version serial numbers were assigned to 20mL and 40mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump.
FDA Determined
Cause 2		 Other
Action The physicians have been notified via letter of the problem with the pump. Appointments will be made with the patients and a Medtronic representative to correct the implanted devices.
Quantity in Commerce 14
Distribution Within the United States and outside the United States.
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.
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