Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
Check against the official notice below — it lists the full affected range.
Advanced Sterilization Products is recalling 1,465 Wall Charts for the STERRAD 100NX Sterilizer System because the charts contain incorrect information. Specifically, the wall charts state that "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators," which is inaccurate. The affected wall charts were distributed nationwide and are identified by multiple lot and code numbers listed in the recall notice.
The recall notice does not specify a remedy or recommended action for consumers who possess affected wall charts.
Written by software from the official notice below. Not reviewed by a lawyer.
Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."
Reason for recall: Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators." Distribution: Nationwide Distribution. Quantity: 1465 units Lot/code info: 1041110428 1041110429 1043141347 1043130246 1041100160 1041100193 1043140260 1041110040 1041120389 1041110125 1043150133 1041090452 1041120062 1041130103 1041070049 1041100128 1043141230 1041100228 1041110512 1041080260 1041100245 1041100325 1041100327 1041100328 1041110513 1043141014 1041080059 1041120039 1043141234 1041110214 1041120483 1041110516 1041120099 1043140161 1043140298 1041100218 1041080204 1043150029 1041120098 1041120108 1041120334 1043141214 1043141222 1041090297 1041120050 1041120051 1043140068 1041090307 1041100235 1041110411 1043141042 1041100219 1041090328 1041110137 1041130401 1041090293 1043150141 10104001070042 10104001070043 1041120390 10104001080074 1041130188 1041130009 1041080082 10104001080031 1041130067 1041130070 10104001080092 1041080188 1041110119 1041120488 1043140137 1041130229 1041090298 1041120061 1041120075 1041120077 1041100288 1041100292 1041080226 1041090350 1041110105 1041110559 1041080078 1041090352 1041120503 1041080185 1041110294 1041120068 1041120025 1041110493 1041120152 1043140124 1041090271 1041080182 1041090303 1041120057 1041120060 1043140054 1041110473 1041090339 1041110057 1041110407 1041120049 1041110515 1041120065 1041120265 1041090280 1041110237 1041090458 1041130155 1041100253 10104001080087 1043140131 1041100060 1043150155 1043150142 1041080179 1041120203 1041110405 1041110443 1043140185 10104001070039 1041090475 1041120139 1041110124 1041110481 10104001070044 1041120476 1041130037 1041090277 1041130150 1043150194 10431
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.