FDAFDA · Alimentos y medicamentos·N.º oficial Z-1485-2017
PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).
Publicado el 29 de marzo de 2017 · Inicio del retiro: 24 de febrero de 2016
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
PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This product contains dry natural rubber" and/or erroneously included the phrase "Latex-free." The white gauze component of the PureWick contains dry natural rubber.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Purewick Corporation
- Distribuidor
- US: Nationwide Distribution
- Lote
- Item # 625
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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