Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Reported: October 24, 2012 Initiated: September 17, 2012 #Z-0081-2013
Product Description
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Reason for Recall
Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 19,716 units distributed total all products
- Distribution
- Distributed in Brazil, Portugal and Hong Kong.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.. Recalled by Boston Scientific Corporation. Units affected: 19,716 units distributed total all products.
Why was this product recalled? ▼
Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2012. Severity: Moderate. Recall number: Z-0081-2013.
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