Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
Publicado el 26 de febrero de 2014 · Inicio del retiro: 20 de diciembre 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
Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps. Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Perrigo Diabetes Care
- Distribuidor
- Nationwide Distribution including GA & TX
- Lote
- 400064, 400069, 400070, & 400072 UPC: 7613117009502
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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