FDAFDA · Food and drugs·Recall number Z-2718-2014
Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Published October 8, 2014 · Recall initiated: July 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St. Jude Medical, Inc.
- Distributor
- Distributed in the states of Texas and Illinois.
- Lot
- Material 100077113, Batch 4558337
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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