FDAFDA · Food and drugs·Recall number Z-0843-2015
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.
Published December 31, 2014 · Recall initiated: November 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Sterilization Products
- Distributor
- Worldwide Distribution.
- Lot
- 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 10101083052 10101952071 10101059212 10101962873 10101006004 10101962708 10101026777 10101006083 101083229 10102984544 10101061310 10101995063 10101984140 10101973409 10101962400 101130068 101094167 10101995139 10101963271 10101963275 10101073361 10101016515 10101973635 10101962551 10101963217 101083271 10101006012 10101962823 10101048901 10101962441 10101061325 10101059257 10101073676 10101048608 10101006114 101120244 10101038255 10101026979 101083525 101094401 10101973576 10101995163 10101073505 10101005879 10101962887 10101016393 10101984458 10101016235 10101984331 10101962443 10101984038 10101026617 10101059428 10101952047 10101962390 10101048600 10101995242 10101048594 10101026924 10101073481 10101061264 10101059599 10101962209 10101952092 10101952091 10101073289 10101026683 10101995371 10101016212 10101952053 10101083112 10101059357 10101973435 10101984090 10101962756 10101995517 10101059344 10101952063 10101061459 10101073110 10101026727 10101073023 101110419 10101995285 10101038420 10101026961 10101026964 10101048671 10101038150 10101073233 10101962625 10101073504 10101950815 10101073526 10101059331 101120190 10101940770 10101984439 10101984466 10101995346 10101995347 10101984286 10101963383 10101026957 10102984534 10101963201 10101984516 10101984138 101094162 101110474 10101048601 10101073271 101083237 10101061269 10101995239 101104636 10101962715 10101061146 101110107 10101952052 10101026895 101083516 10101006116 10101016452 10101995284 10101006098 10101016434 10101962606 10101027061 10101073506 10101038388 101120500 10101963380 101094088 10101952040 10101083088 10101984194 10101038253 10101984179 101104629 101094019 101083285 10101027074 10101038108 10101952082 10101038080 101083339 10101984567 10101026783 10101026988 10101995544 10101073474 10101016314 10101016338 10101059362 10101006129 10101061099 10101073726 10101995164 10101984345 10101016271 10101016310 10101951025 10101962547 10101963294 10101973788 10101952119 10101026621 101104611 10101027010 10101984445 101120080 101083448 10101061321 10101048607 10101038304 10101963370 10101038097 10101027069 10101995325 10101048686 10101048740 10101930403 10101006076 101083517 10101083007 10101940555 10101962565 101120086 10101073730 101104531 10101006014 10101038034 10101083115 101083289 10101016273 10101061175 10101061217 10101026989 10101038086 10101984036 10101973509 10101962227 101105301 101104625 10101973424 10101061147 10101973493 10101995015 10101962337 10101005877 10101059209 10101016359 10101962473 10101952148 10101059571 10101984007 10101006021 10101059388 101140260 10101048920 10101952151 10101962710 10101952038 10101962591 10101995150 10101026932 10101027006 10101083191 101110318 10101962611 10101962217 101094083 101140097 10101016493 101120073 1010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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