FDA MedWatch - Convenience Kits Containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate

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Title: FDA MedWatch - Convenience Kits Containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Convenience Kits Containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate

AUDIENCE: Risk Manager

ISSUE: Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.

See the Recall Notice for a listing of affected lot numbers.

Distribution Dates: May 23, 2016 to October 18, 2016
Devices Recalled in the U.S.: 1,000 kits

BACKGROUND: The Multi-Med Catheter is used to sample blood, and administer drugs or fluids. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel.

RECOMMENDATION: On October 21, 2016, Centurion sent an Urgent Recall Notice letter to all affected customers. The letter asked customers to:

• Identify and stop using the affected products
• Complete and return the response form to the recall coordinator via email to Lcarpenter@xxxxxxxxxxxxxxx or fax 517-546-3356.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532629.htm

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