Events

Recall of Device Recall CUSTOM FLEXIGUIDE NEEDLE, SERIES 15,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alpha Omega Services 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
    49128
  • Event Risk Class
    Class 2
  • Event Number
    Z-0168-2009
  • Event Initiated Date
    2007-11-15
  • Event Date Posted
    2008-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72826
  • 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 - Product Code IWJ
  • Reason
    There is a possibility that the flexiguide needle tip is defective. there is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
  • Action
    Notification of customers initially began November 15, 2007 based on a cursory visual inspection of the defective needle tips. The initial letter advised that there is a possibility that the Flexiguide Needle tip is defective in that there is the potential for the needle's stylet or an HDR source wire/cable to puncture through the defective needle tip during implant or treatment and penetrate the surrounding tissue thereby injuring the patient and/or breaking the sterile boundary. Further distribution and/or use of these products should not take place. The recall notification was updated on November 27,2007 once results from actual testing were available. The letter advises that there is a potential for the needle's tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids. Further distribution and/or use of these products should not take place. Customers are to return the products for credit. A response form is provided. Contact Alpha-Omega Services, Inc. at 1-800-346-7894 for assistance.

Device

Device Recall CUSTOM FLEXIGUIDE NEEDLE, SERIES 15,
  • Model / Serial
    Lot: K00136
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    NV, AZ, CA, MI, UT, MO, CO, and OH
  • Product Description
    Alpha-Omega Services, Inc. Product No: SPECIAL-NFV || Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
  • Manufacturer
    Alpha Omega Services Inc

Manufacturer

Alpha Omega Services Inc
  • Manufacturer Address
    Alpha Omega Services Inc, 9156 Rose Street, Bellflower CA 90706-6420
  • Manufacturer Parent Company (2017)
    Alpha-Omega Services Inc.
  • Source
    USFDA