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Excess Material May Split, Separate from Multi-Med Single Lumen Catheters in Kits


On December 9, 2016, Centurian recalled convenience kits containing Multi-Med Single Lumen Catheters. Centurian indicated that there is the potential for excess material to remain at the tip of the catheter during 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.

 

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.

 

The recalled Centurion Convenience Kits were distributed between May 23, 2016, and October 18, 2016. Multiple lot numbers and kit codes were affected. The product code on all the recalled products is FOZ.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the FDA Safety Alert

 

Also see the Recall

 

See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks 

 

 

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