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Z-0744-2014 Class II Terminated

Recalled by Advanced Sterilization Products — Irvine, CA

FDA device recall Z-0744-2014 was initiated by Advanced Sterilization Products on December 16, 2013 and is designated Class II. 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 S… The recall status is terminated (terminated March 27, 2014). Affected quantity: 5584 units.

Recall Details

Product Type: Devices
Report Date: January 22, 2014
Initiation Date: December 16, 2013
Termination Date: March 27, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5584 units

Product Description

STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX 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.

Distribution Pattern

Nationwide Distribution

Code Information

not available

Other recalls by Advanced Sterilization Products

Z-1197-2017 Class II — STERRAD NX Sterilization System, Product Code: 10033, 10033-002 (January 9, 2017)
Z-0965-2017 Class II — EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 Th (September 27, 2016)
Z-2774-2015 Class II — CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocess (August 10, 2015)
Z-2459-2015 Class II — CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 (July 27, 2015)
Z-2375-2015 Class II — Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer (July 17, 2015)
Z-1714-2015 Class II — EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EV (May 11, 2015)
Z-1715-2015 Class II — EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. Th (May 11, 2015)
Z-1312-2015 Class II — Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 (December 24, 2014)
Z-0844-2015 Class II — STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Ste (November 4, 2014)
Z-0843-2015 Class II — STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD S (November 4, 2014)