FDA Device recall Z-0661-2013
STERRAD NX Cassettes, P/N 10133
- FDA Device
- Class II
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class II recall of STERRAD NX Cassettes, P/N 10133 by Advanced Sterilization Products, citing 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 label….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0661-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-20 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot # 11J037, 11L038, 11J033 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Advanced Sterilization Products
- STERRAD NX Sterilization System, Product Code: 10033, 10033-002
FDA Device · Class II · 2017-02-22 · Advanced Sterilization Products - EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disi…
FDA Device · Class II · 2017-01-18 · Advanced Sterilization Products - CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices
FDA Device · Class II · 2015-09-23 · Advanced Sterilization Products - CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
FDA Device · Class II · 2015-09-02 · Advanced Sterilization Products - Wall Chart for STERRAD 100NX System, P/N 10104
FDA Device · Class II · 2015-08-19 · Advanced Sterilization Products
All Advanced Sterilization Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0661-2013%22
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