Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
Publicado el 7 de febrero de 2024 · Inicio del retiro: 29 de noviembre de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- American Contract Systems, Inc.
- Distribuidor
- US Nationwide distribution.
- Lote
- a) AGTA48J, UDI/DI 00191072142870, lot numbers: 890231, exp. 45402; 920231, exp. 45372; 941231, exp. 45350; 976231, exp. 45315; 645221, exp. 45281; 659221, exp. 45267; 686221, exp. 45240; 755221, exp. 45171; 836221, exp. 45090; b) LLEO66, UDI/DI 00191072165541, lot numbers: 813221, exp. 7/6/2023; 763221, exp. 8/25/2023; 696221, exp. 10/31/2023; 984231, exp. 1/16/2024; 905231, exp. 4/5/2024; c) MMTA41F, UDI/DI none, lot numbers: 899231, exp. 4/11/2024
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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