Events

Recall of Perfectum Tuberculin Glass Syringe, Non sterile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cadence 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
    71674
  • Event Risk Class
    Class 2
  • Event Number
    Z-2364-2015
  • Event Initiated Date
    2015-07-09
  • Event Date Posted
    2015-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138670
  • 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
    Needle, aspiration and injection, disposable - Product Code GAA
  • Reason
    Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
  • Action
    Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Contact Cadence Science, Inc. using the Response Form provided. 4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031

Device

Perfectum Tuberculin Glass Syringe, Non sterile
  • Model / Serial
    Packged Lots:  Catalog Number 5202: 79713-04, 80468-05, W003542/1, W006324/1, W006324/2, W006324/3, W006324/4, W006324/5;  Catalog Number 5205: 79748-03;  Catalog Number 5212: W008136/1, W008686/1, W011240/1, W010905/1, W012135/1, W014053/1, W015838/1, W011240
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign Canada, Denmark. Italy
  • Product Description
    Perfectum Tuberculin Glass Syringe, Non sterile || Catalog numbers 5202, 5205, 5212
  • Manufacturer
    Cadence Inc.

Manufacturer

Cadence Inc.
  • Manufacturer Address
    Cadence Inc., 2080 Plainfield Pike, Cranston RI 02921-2012
  • Manufacturer Parent Company (2017)
    Cadence Inc.
  • Source
    USFDA