STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard ...
FDA Device Recall #Z-0604-2014 — Class II — November 26, 2013
Recall Summary
| Recall Number | Z-0604-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 26, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Sterilization Products |
| Location | Irvine, CA |
| Product Type | Devices |
| 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.
Lot / 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 from Advanced Sterilization Products
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1197-2017 | Class II | STERRAD NX Sterilization System, Product Code: ... | Jan 9, 2017 |
| Z-0965-2017 | Class II | EVOTECH Endoscope Cleaner and Reprocessor Syste... | Sep 27, 2016 |
| Z-2774-2015 | Class II | CIDEX OPA Solution, P/N 20390 for use as a high... | Aug 10, 2015 |
| Z-2459-2015 | Class II | CIDEX Activated Dialdehyde Solution, 4 bottles/... | Jul 27, 2015 |
| Z-2375-2015 | Class II | Wall Chart for STERRAD 100NX System, P/N 10104.... | Jul 17, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.