Events

Recall of Device Recall Customed

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
    72992
  • Event Risk Class
    Class 2
  • Event Number
    Z-1474-2016
  • Event Initiated Date
    2016-01-07
  • Event Date Posted
    2016-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143539
  • 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
    Gown, surgical - Product Code FYA
  • Reason
    Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
  • Action
    Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.

Device

Device Recall Customed
  • Model / Serial
    LOTS: SV15168 (150418240) 30-APR-16 SL15209 (150719850) 31-JUL-16 SL15218 (150719850) 31-JUL-16 SL15229 (150719850) 31-JUL-16 SL15244 (150820336) 31-AUG-16 SL15251 (150719850) 31-JUL-16 SL15252 (150719850) 31-JUL-16 SL15254 (150719850) 31-JUL-16 SL15254 (150820336) 31-AUG-16 SL15257 (150820336) 31-AUG-16 SL15258 (150820336) 31-AUG-16
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 900521 || SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE || Used by medical staff to perform surgical procedures and 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