Events

Recall of CMS2193R7 and CMS1911R3 Custom Biopsy Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Custom Medical Specialties, 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
    76276
  • Event Risk Class
    Class 2
  • Event Number
    Z-1234-2017
  • Event Initiated Date
    2016-09-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152617
  • 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
    Tray, biopsy, without biopsy instruments - Product Code FCH
  • Reason
    Sterility of syringe product could not be assured.
  • Action
    A letter was issued to customers on 9/20/2016 notifying them of the recall of the 10 cc syringe by BD. The letter tells them not to use the syringe in the kit, and to use the syringe on the outside of the kit which is not part of the recall.

Device

CMS2193R7 and CMS1911R3 Custom Biopsy Tray
  • Model / Serial
    Lots 40629-1609 an 40631-1609
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to ID and OR.
  • Product Description
    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
  • Manufacturer
    Custom Medical Specialties, Inc.

Manufacturer

Custom Medical Specialties, Inc.
  • Manufacturer Address
    Custom Medical Specialties, Inc., 330 East Main Street, Pine Level NC 27568
  • Source
    USFDA