Recall of Device Recall PhaSeal Intravascular Administration Set

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

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
    38251
  • Event Risk Class
    Class 2
  • Event Number
    Z-1180-2007
  • Event Initiated Date
    2007-06-26
  • Event Date Posted
    2007-08-22
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-03-05
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Intravascular Administration Set - Product Code FPA
  • Reason
    Risk of leakage: when the phaseal protector and injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. these rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
  • Action
    On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers.

Device

  • Model / Serial
    P21 Cat. No. 22020
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed throughout the US and Canada
  • Product Description
    PhaSeal, Protector 21, Item No. 21, US Order No. 22020
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Carmel Pharma, Inc., 7029 Huntley Road, Suite O, Columbus OH 43229
  • Source
    USFDA