Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Pa
FDA device recall Z-1308-2008 · posted 2008-07-22 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LKK
- Quantity affected
- 18
- Distribution
- Nationwide Distribution including states of MI, OR, IN, NY, FL, PA, MN, TX, CO and UT.
- Date initiated
- 2008-01-09
- Date posted
- 2008-07-22
- Date terminated
- 2010-10-08
- Location
- Minneapolis, MN
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