FDA Device recall Z-0845-2015
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose st…
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose st… 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-0845-2015 |
| 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 NX, Product Code 10133 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 | 33090405 33101190 33120219 33100496 33110562 33130219 33110366 33130465 33111520 33130282 10033071044 331109…33090405 33101190 33120219 33100496 33110562 33130219 33110366 33130465 33111520 33130282 10033071044 33110944 33111953 33120721 33090217 33101176 10033070871 33102083 10033050639 10033060586 33102226 33111924 33101329 33100417 33101016 33111073 33120793 33110111 33090419 33100454 10033060228 10033060960 33111103 10033070692 33101139 33101386 33101053 10033070360 33120921 33120191 10033050160 10033060708 33101575 33130237 10033050205 33120742 33110536 1033141141 33110622 33090535 33090549 10033060991 33120620 33130291 10033060648 33110286 33101395 33120795 10033060743 33101375 33102015 33110760 33100411 33101406 10033060266 10033070410 10033050565 33081285 33110575 33090340 33111511 33101110 33081415 33111660 10033060407 33100166 33100318 33130097 33110043 33081367 33101197 33101343 33100592 33111108 33111413 33120560 33110415 33102140 33130353 33100423 10033060173 33081029 33110958 10033070162 |
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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-0845-2015%22
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