notyard
09-04-2008, 09:52 AM
FDA class II recall:
PRODUCT
a) Medtronic 8578 Sutureless Pump Connector Revision Kit. A part of the Synchro
Med II Infusion system, which is designed to restore and provide intrathecal
administration of drug therapy, Recall # Z-2171-2008;
b) Model 8596SC Intrathecal Catheter Pump Segment Revision Kit. A part of the
SynchroMed II Infusion system, which is designed to restore and provide
intrathecal administration of drug therapy, Recall # Z-2172-2008;
c) Model 8709SC Indura 1P One-Piece Intrathecal Catheter. A part of the
SynchroMed II Infusion system, which is designed to restore and provide
intrathecal administration of drug therapy., Recall # Z-2173-2008;
d) Model 8731SC Intrathecal Catheter. A part of the SynchroMed II Infusion
system, which is designed to restore and provide intrathecal administration of
drug therapy, Recall # Z-2174-2008
CODE
All lots numbers
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter on April 3, 2008. Firm initiated recall is complete.
REASON
The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.
VOLUME OF PRODUCT IN COMMERCE
232 pumps
DISTRIBUTION
Belgium
PRODUCT
a) Medtronic 8578 Sutureless Pump Connector Revision Kit. A part of the Synchro
Med II Infusion system, which is designed to restore and provide intrathecal
administration of drug therapy, Recall # Z-2171-2008;
b) Model 8596SC Intrathecal Catheter Pump Segment Revision Kit. A part of the
SynchroMed II Infusion system, which is designed to restore and provide
intrathecal administration of drug therapy, Recall # Z-2172-2008;
c) Model 8709SC Indura 1P One-Piece Intrathecal Catheter. A part of the
SynchroMed II Infusion system, which is designed to restore and provide
intrathecal administration of drug therapy., Recall # Z-2173-2008;
d) Model 8731SC Intrathecal Catheter. A part of the SynchroMed II Infusion
system, which is designed to restore and provide intrathecal administration of
drug therapy, Recall # Z-2174-2008
CODE
All lots numbers
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter on April 3, 2008. Firm initiated recall is complete.
REASON
The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.
VOLUME OF PRODUCT IN COMMERCE
232 pumps
DISTRIBUTION
Belgium