FDAFDA · Alimentos y medicamentos·N.º oficial Z-3046-2026
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.
Publicado el 9 de septiembre de 2026 · Inicio del retiro: 19 de mayo de 2026
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
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- AVID Medical, Inc.
- Distribuidor
- US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
- Lote
- Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346967; Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346982; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343413; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343414; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343713; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343715; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343716; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343412; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343416; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343714; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343717; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343718; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343719; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343723; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343746; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343747; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343771; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374128; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374129; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374296; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 342005; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 344071; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 347906; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 341835; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343206; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343208; Model/Item Number (kit) MHAC65-01, UDI/DI 10809160479537, Kit Lot Number 345289; Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 345694; Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 341654; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 344464.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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