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U.S. Department of Health and Human Services

Medical Devices

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Four Class I Recalls: Becton, Dickinson (BD) and Company, Q-Syte Luer Access Split Septum and Numerous Products Containing the Q-Syte Luer Access Split Septum Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.

Photo 1. BD Q-Style Luer Access Split SeptumRecall Class: Class I

Date Recall Initiated: October 19, 2009

Products:

Certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products, including kits and trays, sold by other companies in which the Q-Syte Luer Access device is a component, are being recalled. These include:

  • Certain BD Q-Syte Luer Access Split Septum devices
  • Certain BD Nexiva Closed IV Catheter Systems
  • Certain MPS Acacia IV Extension Sets
  • Certain Medical Action Industries IV start bundle kits, venous access trays, and dialysis kits
  • Certain Arrow International central venous access kits and sheath introducer kits

For specific information on the affected products, see the list of recalled devices in the Initial Communication under Useful Links below.

The affected BD products were manufactured from August 1, 2008 through March 12, 2009 and distributed from August 1, 2008 through February 1, 2010.

Use: This device is used with other infusion therapy products to administer therapies (such as chemotherapy), blood and fluids into the intravenous (IV) system.

Recalling Firms:

BD Medical Systems
9450 South State Street
Sandy, Utah 84070-3213

Medical Action Industries, Inc.
25 Heywood Road
Arden, North Carolina 28704-9302

Acacia, Inc.
785 Challenger Street
Brea, California 92821

Arrow International, Inc.
2400 Bernville Road
Reading, Pennsylvania 19605

Reason for Recall: Certain lots of the BD Q-Syte Luer Access Split Septum devices are defective which may result in air bubbles leaking into the infusion system and into the patient’s bloodstream, resulting in an air embolism. In addition, these defective devices may result in leakage of therapy being infused and result in incomplete and inadequate administration of therapy. There is also a potential for blood leakage through this defect. These problems may result in serious injuries or death

Public Contact:

Clinicians or distributors who have questions can contact the companies at:

  • BD at 1-800-453-4538, option 2, extension 2585, between 8:00 AM and 5:00 PM Mountain Time, Monday through Friday, or dial directly at 1-801-565-2300, extension 2585 or 2860.
  • Medical Action Industries at 1-828-681-8820.
  • Acacia at 1-800-486-6677 between 8:00 AM and 5:00 PM, Pacific Time, Monday through Friday, or dial directly at 1-714-257-0470.
  • Arrow International at 1-800-524-8446.

FDA Districts: Denver, Atlanta, Los Angeles, and Philadelphia

FDA Comments:

Between October 28, 2009 and February 8, 2010, the companies sent their customers letters requesting that all unused affected lots be returned. The letters included a response card to be returned whether or not customers had the products in their inventories. The companies sent replacement devices or credited their customers’ accounts. These recalls have not caused shortages of any of these devices.

For additional information, see below under Useful Links.

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: