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STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is ...

FDA Recall #Z-0746-2014 — Class II — December 16, 2013

Recall #Z-0746-2014 Date: December 16, 2013 Classification: Class II Status: Terminated

Product Description

STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S 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

2366 units

Distribution

Nationwide Distribution

Code Information

not available

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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