Home / Recalls / Advanced Sterilization Products / Z-0403-2014

Z-0403-2014 Class II Terminated

Recalled by Advanced Sterilization Products — Irvine, CA

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-0845-2015 Class II — STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Ster (November 4, 2014)
  • Z-0842-2015 Class II — STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Ste (November 4, 2014)