Events

Recall of Device Recall JVAC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, 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
    33336
  • Event Risk Class
    Class 2
  • Event Number
    Z-0076-06
  • Event Initiated Date
    2005-08-31
  • Event Date Posted
    2005-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41712
  • 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
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
  • Reason
    Two lots of j-vac drain reservors were shipped to japan prior to sterilization and were released.
  • Action
    Ethicon notified Japan of the recall on 9/2/2005 via phone call and e-mail. This product is direct shipped from Johnson & Johnson Hospital Services distribution center to Japan JJKK.

Device

Device Recall JVAC
  • Model / Serial
    Product code 2179  Lot 520198, exp June 2010; Lot 520200, exp June 2010.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected.
  • Product Description
    J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.
  • Manufacturer
    Ethicon, Inc

Manufacturer

Ethicon, Inc
  • Manufacturer Address
    Ethicon, Inc, US Highway 22 West, Somerville NJ 08876
  • Source
    USFDA