Events

Recall of Device Recall Huber Infusion Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Exelint International Co..

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
    54203
  • Event Risk Class
    Class 1
  • Event Number
    Z-0640-2010
  • Event Initiated Date
    2009-12-23
  • Event Date Posted
    2010-01-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87830
  • 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
    Hypodermic single lumen needle - Product Code FPA
  • Reason
    Coring of port's septum, which may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port.
  • Action
    Distributors have been advised to cease distribution of any recalled needles and infusion sets; to quarantine any remaining; to document amount on Customer Response Form; to return form to Exel (firm); to arrange for return of product to Exel for credit. Distributors also are advised to share recall notice with all affected customers. Contact phone: 727-827-1922x0 (M-F 9a-5p EST). Contact email: info@exelint.com

Device

Device Recall Huber Infusion Set
  • Model / Serial
    Catalog 27959R Lots: 07F25 08B04 08C29 08E23 08K26 09A10;  Catalog 27959R Lots: 07A19 07D25 09G21;  Catalog 27955R Lots: 07F18 07H23 07K26 08G14 08D10 08E22 08H05 08H23 09G21;  Catalog 27954R Lots: 08E09 08E21 08J22 09B23 09C28;  Catalog 27949R Lots: 07C20 07F26 07H03 07I 20 07I21 07K22 08B26 08E12 08G17 08K25 08L19 09D03 09F16 09G22 09H12;  Catalog 27948R Lots: 07I13 07J09 08G08 08I09;  Catalog 27950R Lots: 08D23 08E01 09D01;  Catalog 27945R Lots: 07A09 07A25 07F19 07G10 07J23 07K13 07L03 08A26 08B01 08B25 08E02 08F16 08H05 08J06 08J21 08K28 08L10 08L17 08L25 09A17 09C23 09C24 09D01 09D29 09E29 09F09 09F17 09G23;  Catalog 27944R Lots: 07A08 07B10 07B13 07B24 07F08 07F15 07G17 07H03 07H10 07J09 07L17 08A11 08C12 08C28 08D08 08F04 08H21 08I22 08K06 08K14 09A17 09A29 09B11 09B17 09D17 09G17;  Catalog 27946R Lots: 07A18 07C30 08D11 09D29 09F16 09G24 09H17;  Catalog 27941R Lots: 07I12 09B12 09C09 09F17 09H17;  Catalog 27940R Lots: 07I11 07L17 08I12 09D17.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (VA TX NV KY OH NH MS NY OH NM DE WA AZ IL PA OR CO FL GA LA UT MI WI NV CA NJ MO IA) and Canada.
  • Product Description
    Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R, 27954R, 27955R, 27958R, 27959R).
  • Manufacturer
    Exelint International Co.

Manufacturer

Exelint International Co.
  • Manufacturer Address
    Exelint International Co., P. O. Box 3194, Culver City CA 90231-3194
  • Manufacturer Parent Company (2017)
    Exelint International Co.
  • Source
    USFDA