Events

Recall of Gown Surgical Non Reinforced XL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Customed, 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
    69448
  • Event Risk Class
    Class 1
  • Event Number
    Z-0253-2015
  • Event Initiated Date
    2014-10-08
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130679
  • 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
    General surgery tray (kit) - Product Code LRO
  • Reason
    Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
  • Action
    Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.

Device

Gown Surgical Non Reinforced XL
  • Model / Serial
    Lot numbers:  113046906 140412564 140513040 140814664
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to Florida, New York and Puerto Rico..
  • Product Description
    Gown Surgical Non Reinforced XL, Catalog number 900-1579. || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Manufacturer Address
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Manufacturer Parent Company (2017)
    Customed Inc
  • Source
    USFDA