Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN) designed to reduce risk of accidental needle sticks to the operators. The lateral port is equipped with a non-return silicone valve and a polypropylene snap cap with a winged polypropylene hub for fastening.
Enforcement
- Recall Number
- Z-0789-2017
- Event ID
- 75742
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smiths Medical ASD Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 28, 2016
- Initiation Date
- November 21, 2016
- Classification Date
- December 18, 2016
- Termination Date
- August 1, 2017
- Address
- 6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States
Description
Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN) designed to reduce risk of accidental needle sticks to the operators. The lateral port is equipped with a non-return silicone valve and a polypropylene snap cap with a winged polypropylene hub for fastening.
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
3120882, 3120883, 3220733
Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
26,750