Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation s
FDA device recall Z-2719-2014 · posted 2014-09-29 · Terminated
Recall details
- Recalling firm
- St. Jude Medical, Inc.
- Reason for recall
- The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
- Action taken
- A field action was initiated with customer letters, dated July 29, 2014, and attached replacement DFUs. The letter identified the affected product and the reason for the recall. The recalling firm requested the consignees refer to the replacement DFU for guidance while using the device, and to discard the international manuals. Questions regarding the letter should be directed to customers' St. Jude Neuromodulation Representative or call the Technical Services Department at 1-800-727-7846.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GZB
- Quantity affected
- 4 units
- Distribution
- Distributed in the states of Texas and Illinois.
- Date initiated
- 2014-07-29
- Date posted
- 2014-09-29
- Date terminated
- 2015-08-21
- Location
- Plano, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS (K123299) | St. Jude Medical Neuromodulation | 2013-01-18 |