Smiths Medical ASD, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0577-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.

Product Classification:

Class II

Date Initiated: July 15, 2016

Date Posted: February 21, 2018

Recall Number: Z-0577-2018

Event ID: 79045

Reason for Recall:

Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.

Status: Terminated

Product Quantity: 1

Code Information:

GS025081

Distribution Pattern:

International Distribution to:Germany

Voluntary or Mandated:

Voluntary: Firm initiated