Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops ...
FDA Recall #Z-1312-2013 — Class II — June 1, 2009
Product Description
Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Reason for Recall
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Recalling Firm
Karl Storz Endoscopy America Inc — El Segundo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9432 units
Distribution
Distributed Nationwide and in Canada.
Code Information
Lot 36836
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated