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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 Posted December 28, 2013
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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