Events

Recall of Device Recall Renasys Port

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew 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
    58935
  • Event Risk Class
    Class 2
  • Event Number
    Z-0875-2012
  • Event Initiated Date
    2010-12-14
  • Event Date Posted
    2012-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100642
  • 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
    Negative pressure wound therapy powered suction pump - Product Code OMP
  • Reason
    On 12/14/2010, smith & nephew, inc. wound management division in st. petersburg, fl recalled their renasys port product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.
  • Action
    Smith & Nephew, Inc., Wound Management sent an URGENT DEVICE RECALL letter dated December 14, 2010, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to immediately identify and isolate the recalled lots in their inventory, complete and fax the response form, and return any affected products to APL Logistics, Inc. in Suwanee, GA. For questions in general, please contact the Customer Care Center at 1-800-876-1261.

Device

Device Recall Renasys Port
  • Model / Serial
    Product Code Number: 66800694 Lot numbers: 50512962, 50512969, 50512974, 50513087, 50514672, 50513073, 50513074, 50517647, 50516110, 50539644, 50539645, 50539646, 50539647, 50555348, 50555349, 50555351, 50539648, 50546339, 50546340, 50548244, 50548245, 50548246, 50548247 and 50548248.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, GA, MA, MI, MO, MS,.NC, NY,OR, TN, and WI. and the countries of: Australia, Canada, China, England, Germany, Ireland and Singapore.
  • Product Description
    ***REF 66800694***Qty 10***smith&nephew;***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. || Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound.
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.
  • Manufacturer Address
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA