CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report
Sterrad 100NX Cassettes The Sterrad Sterilization System recalled
Advanced Sterilization Products is recalling Sterrad 100NX Cassettes The Sterrad Sterilization System is a low temperature general, distributed nationwide in the US. The recall was initiated on 18 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0044-2014
- FDA event ID
- 66317
- Recalling firm
- Advanced Sterilization Products, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2013
- FDA classified
- 22 Oct 2013
- Reported
- 30 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 Sep 2013 | Recall initiated by company | |
| 22 Oct 2013 | Classified by FDA | +34 days |
| 30 Oct 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
Which lots are affected?
Lot# 13F050, 13F051, 13F049
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advanced Sterilization Products
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterrad NX Sterilization System, Product recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Evotech Endoscope Cleaner and Reprocessor System 208V, Product recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Cidex OPA Solution recalled by Advanced Sterilization | Advanced Sterilization Products | Sterility | CA |
| Device | CLASS II | Cidex Activated Dialdehyde Solution/case recalled | Advanced Sterilization Products | Sterility | Nationwide |
| Device | CLASS II | Wall Chart for Sterrad 100NX System recalled by Advanced Sterilization | Advanced Sterilization Products | Sterility | Nationwide |
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| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |