FDA Device recall Z-0846-2015
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose…
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose… by Advanced Sterilization Products, citing advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0846-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-04 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | n/a |
Product
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Reason
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
Identifiers
| code_info | 1041070006 1041110463 1041130010 1041120317 1041110288 1043140062 1041100046 1041110354 1041120503 1041110470…1041070006 1041110463 1041130010 1041120317 1041110288 1043140062 1041100046 1041110354 1041120503 1041110470 1041110535 1043140130 1041080063 1041100017 1041090452 1041120495 1041130225 1041090339 1041120488 1043140028 1041140082 1041120266 1041080194 1043141011 1043140268 1041100179 1041100065 1041110108 1041130141 1041090462 1041110033 1041110428 1041090416 1041130179 1041130391 1041130323 1043141016 1041080098 1041130195 1041110150 1041090392 1041120216 1041120041 1041110089 1041120056 1041130103 1041120215 1041120357 1041110449 1043140031 1041120463 1041100129 1043130282 1041110265 1041100081 1043140313 1041120233 1043140308 1043140131 1041110015 1041100191 1041110045 1041120275 1041130074 1041110301 1041090409 1041110028 1041110030 1041110435 1041110564 1041120386 1041120040 1041120091 1041100007 1041100015 1041090477 1041130058 1041130072 1041110569 1041100215 1041110035 1.0104E+13 1043130134 1041 |
|---|
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-0846-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.