Class 1 Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate · 10 months ago by Jonathan Payne
Class 1 Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate
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.
Centurion Convenience Kits containing Multi-Med Single Lumen Catheters
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
Distribution Dates: May 23, 2016 to October 18, 2016
Devices Recalled in the U.S.: 1,000 kits
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.
Reason for Recall
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.
Who May be Affected
Health care providers using these catheters
All patients undergoing procedures involving these catheters
What to Do
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, attached to recall notice, to the recall coordinator via email via Lcarpenter@centurionmp.com or fax 517-546-3356.
Health care professionals and consumers with questions should contact Centurion Medical Products Corporation at (571)-546-5400 with any questions related to this recall.
Date Recall Initiated:
October 21, 2016
The FDA alerts provided by MedWrench are intended to be helpful reminders, but are not to displace the timely alerts provided by the manufacturers of the products or the FDA directly. You should always consult those services prior to making any final decisions as to the timeliness and accuracy of the FDA alerts we distribute. For more visit www.fda.gov.