Smiths Medical ASD Inc. recalls Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intraven…

Recall date

November 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0789-2017

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.