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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD Cyclesure Biological Indicator

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  Class 2 Device Recall STERRAD Cyclesure Biological Indicator see related information
Date Initiated by Firm November 26, 2013
Date Posting Updated December 28, 2013
Recall Status1 Terminated 3 on March 05, 2014
Recall Number Z-0604-2014
Recall Event ID 66981
510(K)Number K103222  
Product Classification Indicator, biological sterilization process - Product Code FRC
Product 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.
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
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
949-453-6400
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action A customer notification letter was sent to all customers on 11/26/2013 who purchased the STERRAD CYCLESURE Biological Indicator (BI). The letter informs the customer of the problems identified and the actions to be taken. The customer notification letter includes a table with the products on recall which includes the manufacturing dates, lot numbers, expiration dates, and quantity.
Quantity in Commerce 4048 units total (4014 units in US)
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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