Recall Z-0789-2017— Smiths Medical ASD Inc.

Name: FDA recall Z-0789-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-21

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2016-11-21, terminated 2017-08-01. It names one FDA 510(k) clearance: K012128. 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.. 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Terminated: 2017-08-01
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K012128 — PROTECTIV ACUVANCE IV CATHETER SYSTEMEthicon Endo-Surgery, Inc.·cleared 2001-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.