Events

Recall of Device Recall Irrigation Tray w/Bulb syringe

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
    60753
  • Event Risk Class
    Class 2
  • Event Number
    Z-1252-2012
  • Event Initiated Date
    2011-12-08
  • Event Date Posted
    2012-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106398
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • Reason
    The firm has determined that there is a possibility that packaging seals may be compromised. the issue could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Action
    Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.

Device

Device Recall Irrigation Tray w/Bulb syringe
  • Model / Serial
    lot# 111010005, 111030737, 111030813, 111040954, 111051356, 111061630, 111071948, 111092564
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution - including Florida and Puerto Rico.
  • Product Description
    Irrigation Tray w/Bulb syringe, catalog# 900-020
  • 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