Events

Recall of RK Epidural Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Epimed International, 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
    74018
  • Event Risk Class
    Class 2
  • Event Number
    Z-0086-2017
  • Event Initiated Date
    2016-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145925
  • 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
    Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
  • Reason
    There is a possibility that the needles may have the potential to skive a catheters outer coating. if this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
  • Action
    On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. Once the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0209 or 518-514-1891). Further questions, please call (518) 725-0209.

Device

RK Epidural Needle
  • Model / Serial
    1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AL, AK, FL, IN, TN & TX
  • Product Description
    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 || Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
  • Manufacturer
    Epimed International, Inc.

Manufacturer

Epimed International, Inc.
  • Manufacturer Address
    Epimed International, Inc., 141 Sal Landrio Dr, Crossroads Business Park, Johnstown NY 12095-3835
  • Manufacturer Parent Company (2017)
    Epimed International Inc
  • Source
    USFDA