Events

Recall of Device Recall PulmoSal

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pharmacaribe llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73053
  • Event Risk Class
    Class 2
  • Event Number
    Z-0795-2016
  • Event Initiated Date
    2015-12-29
  • Event Date Posted
    2016-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142921
  • Notes / Alerts
    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.
  • Extra notes in the data
    Nebulizer (direct patient interface) - Product Code CAF
  • Reason
    Vials were labeled as usp 7% hypertonic saline instead of pulmosal 7% (ph+).
  • Action
    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
  • Model / 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)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of FL, LA, TX and VA
  • Product Description
    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
  • Manufacturer Address
    Pharmacaribe llc, 3513 Dileuca St, Punta Gorda FL 33950-7835
  • Manufacturer Parent Company (2017)
    Pharmacaribe Llc.
  • Source
    USFDA