Device product
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.
Z-0789-2017
Product summary
- Event
- Event 75742
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,750
- Official record key
device-enforcement:Z-0789-2017
Official wording
Reason: 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.
Code information: 3120882, 3120883, 3220733
Distribution pattern: Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Derived failure modes
-
Unknown
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.