FDAFDA · Alimentos y medicamentos·N.º oficial Z-1053-2013
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
Publicado el 10 de abril de 2013 · Inicio del retiro: 26 de febrero de 2013
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
LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cooper Surgical, Inc.
- Distribuidor
- Nationwide Distribution including Puerto Rico
- Lote
- Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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