Smiths Medical Asd Inc: Medical Device Recall in 2015 - (Recall #: Z-1730-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 4, 2015

Date Posted: June 17, 2015

Recall Number: Z-1730-2015

Event ID: 71142

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.

Status: Terminated

Product Quantity: 6,000 units

Code Information:

Product Reorder Number: 537235C; Lot #2761409

Distribution Pattern:

Distributed to the states of KY, MN, NJ, UT, & WI.

Voluntary or Mandated:

Voluntary: Firm initiated