Centurion Convenience Kits containing Multi-Med Single Lumen Catheters are subject to a recall due to Excess Material that May Split or Separate. This device 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.
However, when this dangerous situation occurs, excess material may remain at the tip of the catheter from the manufacturing process. The excess material may separate from the catheter during use and enter the patient’s bloodstream.
Adverse Effects
According to the FDA Press Release, the FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Excess material entering the bloodstream may result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.
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Centurion Catheters Recall Information
Centurion Convenience Kits containing Multi-Med Single Lumen Catheters
Centurion Kit Codes: ECVC1680, ECVC4785, M11620HKIC, M11620HKICNL, M11620HS, M11620KC, M11620KCNL, M12013K, M12013KNL
Product Code: FOZ
Distribution Dates: May 23, 2016 to October 18, 2016
Devices Recalled in the U.S.: 1,000 kits
For specific lot numbers included in the Centurion Catheters Recall, visit FDA Centurion Catheters Recall Announcement.
