| Class 2 Device Recall Synchromed II | |
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 |
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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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