Events

Recall of Device Recall FLAT DRAIN 10MM, CHARIKERJETER DRESSING KITS (LARGE AND SMALL)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith And Nephew, Inc. Wound Management Division.

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
    47521
  • Event Risk Class
    Class 3
  • Event Number
    Z-1620-2008
  • Event Initiated Date
    2008-03-31
  • Event Date Posted
    2008-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69660
  • 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
    Pump, portable, aspiration (manual or powered) - Product Code BTA
  • Reason
    Incorrect labeling. kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.
  • Action
    Consignees were notified of recall by letter (Correction and Removal Notification) sent to customers on 3/31/08. They were asked to check their stocks, identify, and return all affected units to Smith & Nephew according to the instructions. Consignees are to contact the Customer Care Center at 1-800-876-1261, if they have additional questions.

Device

Device Recall FLAT DRAIN 10MM, CHARIKERJETER DRESSING KITS (LARGE AND SMALL)
  • Model / Serial
    Lot numbers: 517141, 517269, 517143, and 517108
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. || Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.
  • Manufacturer
    Smith And Nephew, Inc. Wound Management Division

Manufacturer

Smith And Nephew, Inc. Wound Management Division
  • Manufacturer Address
    Smith And Nephew, Inc. Wound Management Division, 11775 Starkey Road, Largo FL 33773-4727
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA