Home / Recalls / Advanced Sterilization Products / Z-1312-2015

Z-1312-2015 Class II Terminated

Recalled by Advanced Sterilization Products — Irvine, CA

FDA device recall Z-1312-2015 was initiated by Advanced Sterilization Products on December 24, 2014 and is designated Class II. Reason for recall: Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013. The recall status is terminated (terminated September 4, 2015). Affected quantity: 2 units.

Recall Details

Product Type
Devices
Report Date
April 1, 2015
Initiation Date
December 24, 2014
Termination Date
September 4, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

Reason for Recall

Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.

Distribution Pattern

Saudi Arabia and Portugal

Code Information

Lot No. 68965-1241

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

FDA data resources