Class 1 Device Recall Centurion

• Date Initiated by Firm: October 21, 2016
• Date Posted: December 02, 2016
• Recall Status: Terminated on July 20, 2017
• Recall Number: Z-0647-2017
• Recall Event ID: 75536
• 510(K)Number: K955839
• Product Classification: Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
• Product: Multi-Med Single Lumen Catheters sold in Centurion convenience kits.; The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
• Code Information: Centurion Kit Code ECVC1680 Kit Description SINGLE LUMEN INSERTION BUNDLE Lot Number(s) 2016062150 2016062950 2016070650 Centurion Kit Code ECVC4785 Kit Description SINGLE LUMEN BUNDLE Lot Number(s) 2016081550 Centurion Kit Code M11620HKIC Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016051050 2016053150 2016060750 2016061550 2016063050 2016072050 2016080250 2016091950 Centurion Kit Code M11620HKICNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016060750 2016072650 2016093050 2016101050 Centurion Kit Code M11620HS Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016052050 2016062850 2016082350 2016082650 2016090250 Centurion Kit Code M11620KC Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016050950 2016053150 2016060750 2016071250 2016080350 2016082950 Centurion Kit Code M11620KCNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm) Lot numbers 2016060850 2016061650 2016062050 2016070550 2016071950 2016080250 2016090750 Centurion Kit Code M12013K Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm) Lot numbers 2016071350 2016072050 2016092650 2016100650 Centurion Kit Code M12013KNL Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm) Lot numbers 2016072950 2016082450
• Recalling Firm/ Manufacturer: Centurion Medical Products Corporation; 100 Centurion Way; Williamston MI 48895-9086
• For Additional Information Contact: 517-546-5400
• Manufacturer Reason for Recall: The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
• FDA Determined Cause: Process control
• Action: Centurion sent an Urgent Recall Notice dated October 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of this product immediately, and forward a copy of this notice to other users to whom this product may have been further distributed. In addition, customers were instructed to complete the attached form at their earliest convenience and fax to 517-546-3356. For questions regarding this recall call 517-546-5400.
• Quantity in Commerce: 1000 kits
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FOZ and Original Applicant = BAXTER EDWARDS