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Z-0403-2014 Class II Terminated

Recalled by Advanced Sterilization Products — Irvine, CA

FDA device recall Z-0403-2014 was initiated by Advanced Sterilization Products on November 11, 2013 and is designated Class II. Reason for recall: Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the s… The recall status is terminated (terminated January 22, 2014). Affected quantity: Total 4,381 units.

Recall Details

Product Type: Devices
Report Date: December 4, 2013
Initiation Date: November 11, 2013
Termination Date: January 22, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Total 4,381 units

Product Description

STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Reason for Recall

Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.

Distribution Pattern

Nationwide Distribution

Code Information

Please refer to consignee list

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-1715-2015 Class II — EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. Th (May 11, 2015)
Z-1714-2015 Class II — EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EV (May 11, 2015)
Z-1312-2015 Class II — Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 (December 24, 2014)
Z-0843-2015 Class II — STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD S (November 4, 2014)
Z-0846-2015 Class II — STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD S (November 4, 2014)