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U.S. Department of Health and Human Services

Medical Devices

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Exelint International Inc. - Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion Sets

Recall Classification: Class I

Date Recall Initiated: December 23, 2009

Product Names:

  • Exel Huber Needles
  • EXELint Huber Needles
  • Exel Huber Infusion Sets
  • EXELint Huber Infusion Sets
  • Exel "Securetouch+" Huber Safety Sets
  • EXELint Huber Safety Sets

ALL LOT NUMBERS BEGINNING WITH 07, 08, OR 09 ARE AFFECTED BY THIS RECALL.

To find all the affected catalog and lot numbers, see under Useful Links below.

These devices were manufactured from February 22, 2007 through September 17, 2009.

Use:

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

Recalling Firm:

Exelint International Co.
P.O. Box 3194
Culver City, California 90231-3194

Reason for Recall:

Inspections conducted in October 2009 of the company’s facilities found that their needles "cored" in 60 to 72 percent of tests. These cores can cause the ports to leak and they can also potentially enter a patient’s body when the port is initially accessed and flushed. These issues may lead to the decreased effectiveness of the port, replacement of the port, infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs. These issues may potentially cause death.

Public Contact:

The company may be contacted at 1-800-940-3935 from 9 AM to 5 PM, Monday through Friday, Eastern Time.

FDA District: Los Angeles

FDA Comments:

The company has advised:

Distributors:
  • STOP distributing all recalled needles and infusion sets.
  • Quarantine all remaining products and document the amount on-hand using the Customer Response Form.
  • Return form to Exel as soon as possible.
  • Arrange for return of the products to Exel for credit.
  • Pass on the recall notice to all affected customers and distributors.
Users:
  • STOP using all recalled needles and infusion sets.
  • Quarantine all remaining products.
  • Arrange for return of the products to Exel for credit.
  • Contact your physician immediately to verify the port has not been damaged if you believe your port was accessed with these needles.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAX. See link below.

Useful Links: