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.
Check against the official notice below — it lists the full affected range.
Advanced Sterilization Products is recalling STERRAD System cassettes (product code 10113) used with STERRAD Sterilization System equipment, which is a low-temperature sterilizer. 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 127 specific lot codes. The source document does not specify what consumers should do in response to 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: 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 101019
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.