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.
Check against the official notice below — it lists the full affected range.
Advanced Sterilization Products is recalling STERRAD System cassettes (product code 10133) used with STERRAD Sterilization Systems, which are low-temperature sterilizers for medical equipment. The recall affects 19,978 units worldwide, including 9,792 units in the United States. The cassettes are being recalled because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
The recall involves cassettes from multiple lot codes listed in the notice. The source document does not specify what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution. Quantity: 19,978 units total (9,792 units in US) Lot/code info: 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 10033080326 33111513 10033080222 33090107 33090352 33090118 33111583 33090560 10033060942 33111555 33110481 33101447 10033070646 33111790 33100545 33111940 33102257 33111983 33111904 33120723 33110218 10033080304 33120450 33120497 33120540 33120543 33130027 33100483 33100418 33100422 33100032 33110838 33111228 10033060274 33120838 33101567 33101002 10033070254 33111685 33050422 33110188 33110544 1033141029 1033142008 33111618 33111915 33090506 10033070765 33090385 33111025 10033060205 33111516 33110553 33111488 33110588 33130181 33101526 33090480 33130031 33101163 33130273 10033060638
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.