Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters because there is the potential for excess material to remain at the tip of the catheter from the manufacturing process, which can separate from the device during use and enter the patient’s bloodstream. If this occurs, it could result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.
The recall is categorized as a Class I, the most serious type of recall because use of the devices may cause serious injuries or death.
Affected Centurion Convenience Kits containing Multi-Med Single Lumen Catheters include Lot Numbers: 2016062150, 2016062950, 2016070650, 2016081550, 2016051050 2016053150, 2016060750, 2016061550, 2016063050, 2016072050, 2016080250, 2016091950, 2016060750, 2016072650, 2016093050, 2016101050, 2016052050, 2016062850, 2016082350, 2016082650, 2016090250, 2016050950, 2016053150, 2016060750, 2016071250, 2016080350, 2016082950, 2016060850, 2016061650, 2016062050, 2016070550, 2016071950, 2016080250, 2016090750, 2016071350, 2016072050, 2016092650, 2016100650, 2016072950, 2016082450, Centurion Kit Codes: ECVC1680, ECVC4785, M11620HKIC, M11620HKICNL, M11620HS, M11620KC, M11620KCNL, M12013K, M12013KNL, Product Code: FOZ, with the Distribution Dates: May 23, 2016 to Oct. 18, 2016. A total of 1,000 kits in the U.S. are affected.
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.
Centurion sent an Urgent Recall Notice to customers with affected device. Patients who have experienced adverse events after being treated with these devices should report the incident to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.