Events

Retiro De Equipo (Recall) de Device Recall PulmoSal

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Pharmacaribe llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    73053
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0795-2016
  • Fecha de inicio del evento
    2015-12-29
  • Fecha de publicación del evento
    2016-02-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142921
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Nebulizer (direct patient interface) - Product Code CAF
  • Causa
    Vials were labeled as usp 7% hypertonic saline instead of pulmosal 7% (ph+).
  • Acción
    PharmaCaribe, together with its Contract Manufacturing firm Asept Pak, Inc., have initiated or completed the following actions to issued an Urgent Notice: Field Notification to Medical Device letter dated January t7, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Determine what is on hand and what has been distributed. Using the Return Notice provided, report this information as per the instructions on the notice. Please record units as either cases or as cartons (if the cases have been opened and are partial). This document is to be returned via mail or email as per the guidance provided. This will inform the Manufacturer of your inventory status and of your intentions regarding product replacement. Cases of this product may be returned for new cases of the same product (different lot) that have the correct embossing on the vials. Instructions for return are provided in the Field Notification Package Cover Letter. Alternatively, customers may choose to be issued a full refund for all returned product. For cases which have already been distributed to the retail/clinician level and/or are in use by patients, it is acceptable to continue to use the product, with the understanding (and proper communication to all parties) that the tabs on the vials are incorrectly labeled. Contact information: Lisa Early, QA Manager Asept Pak, Inc. Phone: 518-651-2026 Fax: 518-651-2046 E-mail: learly@aseptpak.com

Device

Device Recall PulmoSal
  • Modelo / Serial
    Lot # CIY Exp.Date August 2017 UPC Number: 030915339988 (on the box of 60 vials) UPC Number: 10030915339985 (on the shipping case of 12 boxes)
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of FL, LA, TX and VA
  • Descripción del producto
    PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 || For Inhalation Only Rx || Product Usage: || The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.
  • Manufacturer
    Pharmacaribe llc

Manufacturer

Pharmacaribe llc
  • Dirección del fabricante
    Pharmacaribe llc, 3513 Dileuca St, Punta Gorda FL 33950-7835
  • Empresa matriz del fabricante (2017)
    Pharmacaribe Llc.
  • Source
    USFDA