Events

Recall of 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
    79199
  • Event Risk Class
    Class 3
  • Event Number
    Z-0899-2018
  • Event Initiated Date
    2017-10-03
  • Event Date Posted
    2018-02-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161625
  • 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
    Sterile pouches are missing labels on them. the boxes themselves are properly labeled. the issue is related to the production lot p1607442 only.
  • Action
    An Urgent Medical Device Correction letter, dated October 03, 2017, was sent to the customer. The letter identified the affected device and the reason for the recall. The letter instructed the consignee to check its stock in order to remove all mislabeled product from the market and eliminate potential risk of misuse. The customer was instructed to return the completed Confirmation Sheet to Degania Silicone, as well as any unlabeled product. Questions regarding the recall should be directed to Katia Kayam, Customer Complaints Officer at Katia@ds-il.com.

Device

Jackson Pratt" Channel drain
  • Model / Serial
    Lot No P1607442.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to Puerto Rico.
  • Product Description
    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. || Used for the drainage of body fluids for surgical use.
  • 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