FDAFDA · Alimentos y medicamentos·N.º oficial Z-0434-2014
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
Publicado el 11 de diciembre de 2013 · Inicio del retiro: 3 de octubre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Advanced Sterilization Products
- Distribuidor
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal.
- Lote
- Batch numbers: Batch 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1071641 1071641 1030704 1030704 1071641 1030704 1071641 1071641 1071641 1071641 1030704 1030704 1071641 1071641 1071641 1079723 1079723 1079723 1079723 1079723 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1071641 1081088 1081092 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1082503 1081090 1081090 1081090 1081090 1082501 1082501 1082503 1082503 1082503 1082503 1082503 1082503 1082503 1082501 1082501 1082501 1082501 1082501 1082503 1082503 1082503 1081092 1082503 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1085115 1081092 1081092 1081092 1086020 1086020 1086020 1086020 1086424 1086424 1081090 1086423 1087992 1086423 1082501 1081088 1085115 1085115 1086020 1081090 1087992 1086423 Batch 1030705 1030705 1030705 1030705 1030705 1030705 1030705 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1030705 1030705 1030705 1030705 1030705 1030705 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1079627 1079627 1079627 1079626 1079626 1079627 1079626 1079626 1079963 1079963 1079963 1080892 1079963 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1079963 1080892 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1080890 1079963 1080890 1080890 1080890 1080890 1081084 1081084 1081084 1080890 1080890 1081084 1081084 1080890 1080890 1080890 1081084 1081084 1081084 1081084 1081084 1081084 1081084 1082390 1081084 1082390 1082390 1081084 1082390 1084584 1084584 1084584 1085118 1085118 1085118 1082390 1082390 1082390 1082390 1085118 1082390 1082390 1082390 1081084 1082390 1081084 1085118 1086341 1081084 1081084 1085118 1086341 1081084 1081084 1081084 1081084 1081084 1081084 1085118 1085745 1085745 1085461 1085461 1085461 1085461 1084584 1085461 1084584 1084584 1084584 1084584 1084584 1084584 1085461 1085461 1084584 1085461 1085461 1085461 1085461 1085461 1085461 1085461 1087308 1087669 1088431 1085745 1084584 1086341 1084584 1087669 1087308 1085461 1088431 1084584 1085745 1085745 1087669 1087308 1085461 1088431 1084584 1087669 1087308 1085461 Batch 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1071643 1030706 1030706 1030706 1030706 1030706 1071643 1071643 1071643 1071643 1071643 1030706 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1079624 1079624 1079624 1079624 1030706 1030706 1079624 1079624 1081076 1081076 1081076 1081076 1081076 1081076 1081076 1081076 1079624 1081076 1081076 1081076 1081076 1081076 1081076 1081080 1071643 1081080 1071643 1081080 1071643 1081078 1081078 1081078 1081080 1082395 1081078 1081080 1081078 1081080 1081080 1082395 1081078 1081078 1081080 1082395 1081078 1081082 1085117 1085119 1081080 1082395 1081078 1085117 1081082 1085117 1085119 1081080 1085750 1082395 1085887 1081078 1085117 1085117 1085119 1081080 1085750 1082395 1082395 1085887 1085887 1085117 1085119 1085119 1082396 1081080 1085750 1082395 1085887 1081078 1085117 1085119 1085119 1088721 1082396 1081080 1085750 1082395 1081082 1085887 1085117 1081078 1081080 1081082 1085119 1085750
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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