FDA Device recall Z-2338-2012
STERRAD NX Cassette, Batch # 12A078
- FDA Device
- Class III
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class III recall of STERRAD NX Cassette, Batch # 12A078 by Advanced Sterilization Products, citing advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cas….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2338-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-06-19 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and 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 Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
Reason
Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
Identifiers
| code_info | Product Code: 10133 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2338-2012%22
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