FDAFDA · Alimentos y medicamentos·N.º oficial Z-2674-2026
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
Publicado el 8 de julio de 2026 · Inicio del retiro: 9 de junio 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
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer Surgical Inc
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
- Lote
- Lot Code: Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271022(10)79701946 ; Box (10-Pack) UDI (01)00889024380455(17)271022(10)79701946 ; Individual UDI (01)00889024376786(17)271022(10)79701946 ; Lot Number 79701946 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271028(10)79701947 ; Box (10-Pack) UDI (01)00889024380455(17)271028(10)79701947 ; Individual UDI (01)00889024376786(17)271028(10)79701947 ; Lot Number 79701947 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271030(10)79701948 ; Box (10-Pack) UDI (01)00889024380455(17)271030(10)79701948 ; Individual UDI (01)00889024376786(17)271030(10)79701948 ; Lot Number 79701948 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280325(10)80555938 ; Box (10-Pack) UDI (01)00889024380455(17)280325(10)80555938 ; Individual UDI (01)00889024376786(17)280325(10)80555938 ; Lot Number 80555938 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280402(10)80555939 ; Box (10-Pack) UDI (01)00889024380455(17)280402(10)80555939 ; Individual UDI (01)00889024376786(17)280402(10)80555939 ; Lot Number 80555939 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280326(10)80555940 ; Box (10-Pack) UDI (01)00889024380455(17)280326(10)80555940 ; Individual UDI (01)00889024376786(17)280326(10)80555940 ; Lot Number 80555940 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280911(10)80581869 ; Box (10-Pack) UDI (01)00889024380455(17)280911(10)80581869 ; Individual UDI (01)00889024376786(17)280911(10)80581869 ; Lot Number 80581869 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280331(10)80581870 ; Box (10-Pack) UDI (01)00889024380455(17)280331(10)80581870 ; Individual UDI (01)00889024376786(17)280331(10)80581870 ; Lot Number 80581870 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280402(10)80765021 ; Box (10-Pack) UDI (01)00889024380455(17)280402(10)80765021 ; Individual UDI (01)00889024376786(17)280402(10)80765021 ; Lot Number 80765021
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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