FDAFDA · Alimentos y medicamentos·N.º oficial Z-0174-2026
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
Publicado el 22 de octubre de 2025 · Inicio del retiro: 4 de septiembre de 2025
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
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- American Contract Systems Inc.
- Distribuidor
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Lote
- BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421; CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370; IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124; MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A; PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184; UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283; UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number 17598793 * If Bag serial number is listed as "N/A", then whole lot is affected
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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