Recall Z-1730-2015— Smiths Medical Asd Inc

Name: FDA recall Z-1730-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-04

Class II · Terminated

Class II FDA medical device recall by Smiths Medical Asd Inc, initiated 2015-05-04, terminated 2016-01-20. It names one FDA 510(k) clearance: K831087. Product: Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.. Reason: Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product..

Recalling firm: Smiths Medical Asd Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-04
Terminated: 2016-01-20
Firm location: Dublin, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K831087 — MINI-VOL EXTENSION SETBeech Medical, Inc.·cleared 1983-04-28

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

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

Reason for recall

Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

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