FDAFDA · Alimentos y medicamentos·N.º oficial Z-1942-2018
Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10 (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10 (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10 (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10 (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10 (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10 (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10 (m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3003-R-39, QTY 10 (n) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF G-40-1102, QTY 10 Intended for use in coagulating tissue.
Publicado el 6 de junio de 2018 · Inicio del retiro: 11 de mayo de 2018
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
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Olsen Medical
- Distribuidor
- Worldwide Distribution
- Lote
- all codes
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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