FDA Device recall Z-0843-2015
STERRAD 100S, Product Code 10113
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of STERRAD 100S, Product Code 10113 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-0843-2015 |
| 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 100S, Product Code 10113. 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 | 10101038398 10102984490 10101061085 10101006013 10101962406 10101016311 10101026708 101083328 10101016316 1010…10101038398 10102984490 10101061085 10101006013 10101962406 10101016311 10101026708 101083328 10101016316 10101061144 10101016449 10101083087 10101006100 10101048602 101104680 10101016420 10101083507 10101973506 10101962610 101094102 10101073735 10101973491 10101962462 10101038169 10101048613 10101059369 10101061101 10101995598 10101006162 10101984454 10101984119 10101038147 10101026626 10101061509 10101073741 10101962546 10101962882 10101073729 10101026724 10101005913 10101038256 10101984290 10101059615 10101995219 10101059538 10101930412 10101061045 10101984170 101110322 10101016409 10101048663 10101963281 101110554 10101006065 10101038254 10101016279 101083249 10101962822 10101031012 10101984146 10101962593 10101073226 10101048648 10101048860 10101016503 10101006062 10101073256 10101048777 10101973618 101105300 101110522 10101006011 10101995293 10101038387 10101963216 10101963379 10101026711 10101962718 10 |
|---|
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-0843-2015%22
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