Events

Recall of Device Recall Remington Medical, Inc. Automatic Cutting Needle

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
    57885
  • Event Risk Class
    Class 2
  • Event Number
    Z-1576-2011
  • Event Initiated Date
    2011-02-07
  • Event Date Posted
    2011-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97669
  • 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
    Soft Tissue Biopsy Needle - Product Code KNW
  • Reason
    There is a potential for the needle hubs to break during use.
  • Action
    Remington Medical consignees were notified via facsimile, email and certified mail starting 02/07/2011. Distributors are requested to communicate this recall to their customers. If a customer does not respond to the recall notice within one week of the recall notification, the customer will be contacted by telephone. If this is unsuccessful, the customer will be sent a second Recall Notice letter and Customer Inventory Reconcile Fax by certified mail by 28 February 2011. If there is no response at that point, RMI will consider the customer's inventory depleted. All return product for this recall will follow RMIs Returns Goods Authorization procedure (SOP7-200). All product returns and customer responses will be documented. Upon completion of the recall, the status will be updated and submitted for the FDA's recall closure process.

Device

Device Recall Remington Medical, Inc. Automatic Cutting Needle
  • Model / Serial
    Lot numbers: 090212, 091351 and 093136
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide
  • Product Description
    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
  • 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