Events

Recall of Device Recall Jackson Pratt" Channel drain

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

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
    76368
  • Event Risk Class
    Class 2
  • Event Number
    Z-1233-2017
  • Event Initiated Date
    2017-01-31
  • Event Date Posted
    2017-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152988
  • 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
    Catheter, irrigation - Product Code GBX
  • Reason
    Product sterility compromised due to breach of sterile barrier.
  • Action
    Degania Silicone Ltd. issued an Urgent Recall letter dated 1/31/17 and requested return of the product to Degania Silicone 14 Thurber Boulevard, Suite A, Smithfield, RI 02917, USA.. For questions regarding this recall call +1-401-349-5373.

Device

Device Recall Jackson Pratt" Channel drain
  • Model / Serial
    Lot Number: P1546816 Expiration date: January 2021
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    To PR only
  • Product Description
    Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx || Distributed by Cardinal Health, USA || Catalog Number: JP-2187 || For wound drainage.
  • Manufacturer
    Degania Silicone, Ltd.

Manufacturer

Degania Silicone, Ltd.
  • Manufacturer Address
    Degania Silicone, Ltd., Degania Bet, Dganya Bet Israel
  • Manufacturer Parent Company (2017)
    Q International Holding Ltd.
  • Source
    USFDA