Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS
FDA device recall Z-0858-2015 · posted 2014-12-23 · Terminated
Recall details
- Recalling firm
- Cyberonics, Inc
- Reason for recall
- The recalled product was distributed with an incorrect serial number printed on the device's label.
- Action taken
- The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LYJ
- Quantity affected
- 1 unit
- Distribution
- Distributed to PA.
- Date initiated
- 2014-11-20
- Date posted
- 2014-12-23
- Date terminated
- 2016-02-08
- Location
- Houston, TX
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