FDA Device

Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)

Hazard

Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

What You Should Do

Remedy

A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.

Products

Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
Brand
Sanarus Medical Inc
UPC
Lot # C030404

Units Affected

41