Events

Recall of Device Recall Chiba Needle Marked

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remington Medical 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
    52781
  • Event Risk Class
    Class 2
  • Event Number
    Z-1935-2009
  • Event Initiated Date
    2009-06-19
  • Event Date Posted
    2009-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83992
  • 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
  • Reason
    Two unsealed pouches were identified after product release, compromising product sterility.
  • Action
    Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers.

Device

Device Recall Chiba Needle Marked
  • Model / Serial
    Lot number 091386.
  • Distribution
    US - CA and WI.
  • Product Description
    Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. || General purpose aspiration Cytology Biopsy Needle
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • Manufacturer Address
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • Manufacturer Parent Company (2017)
    Remington Medical, Inc.
  • Source
    USFDA