Events

Recall of Device Recall Kimberly Clark Ultra Surgical Gown

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kimberly-Clark Corporation.

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
    57535
  • Event Risk Class
    Class 2
  • Event Number
    Z-0920-2011
  • Event Initiated Date
    2010-12-23
  • Event Date Posted
    2011-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96481
  • 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
    Surgical Gown - Product Code FYA
  • Reason
    Product was not properly sterilized.
  • Action
    Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The Distributor is instructed to immediately cease further shipment of the product and to physically quarantine the product, and fax the completed Response Sheet to our firm's Recall Coordinator within 5 business days of receipt of the letter. The Customer is instructed to immediately cease further use of the gowns and physically quarantine the product, and fax the completed Customer Product Response Sheet to Kimberly Clark's Recall Coordinator within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, the firm will provide instructions for the return of the impacted gowns for delivery to a quarantine location at our warehouse.

Device

Device Recall Kimberly Clark Ultra Surgical Gown
  • Model / Serial
    Product code (Large Surgical Gowns): 95111-35, Case Lot Numbers: AH0319YL0, AH0319YLI, AH0319YM4, AH0319YLH, AH0319YLJ, AH0319YM3, AH0320YMD, AH0320YME, AH0320YMF, AH0320YMG, AH0320YMN, AH0320YMM, AH0320YMH, AH0320YN0, AH0320YNC, AH0320YND, AH0320YNJ, AH0320YNI, AH0320YNK; Individual Unit Lot Numbers (printed on the sterile pouch): AH0319A, AH0319B, AH0319C, AH0320A, AH0320B, AH0320C.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
  • Product Description
    Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Manufacturer Address
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA