STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a ge...
FDA Recall #Z-0745-2014 — Class II — December 16, 2013
Product Description
STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Reason for Recall
Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
Recalling Firm
Advanced Sterilization Products — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
233 units
Distribution
Nationwide Distribution
Code Information
not available
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated