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.
Enforcement
- Recall Number
- Z-0647-2017
- Event ID
- 75536
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Centurion Medical Products Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 14, 2016
- Initiation Date
- October 21, 2016
- Classification Date
- December 2, 2016
- Termination Date
- July 20, 2017
- Address
- 100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States
Description
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.
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.
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
Nationwide Distribution
1000 kits