STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature gen...
FDA Device Recall #Z-0661-2013 — Class II — September 20, 2012
Recall Summary
| Recall Number | Z-0661-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 20, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Sterilization Products |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 12,280 units |
Product Description
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Reason for Recall
Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.
Lot / Code Information
Lot # 11J037, 11L038, 11J033
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.