Home / Recalls / Advanced Sterilization Products / Z-0604-2014

Z-0604-2014 Class II Terminated

Recalled by Advanced Sterilization Products — Irvine, CA

Recall Details

Product Type
Devices
Report Date
January 8, 2014
Initiation Date
November 26, 2013
Termination Date
March 5, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4048 units total (4014 units in US)

Product Description

STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

Reason for Recall

Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.

Distribution Pattern

Worldwide Distribution.

Code Information

Batch/Lot No. 14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106

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-0844-2015 Class II — STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Ste (November 4, 2014)
  • Z-0845-2015 Class II — STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Ster (November 4, 2014)