FDA recall Z-0577-2018

Product

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.

Reason for recall

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

Distribution

International Distribution to:Germany

Key facts

Status

Terminated

Initiation date

2016-07-15

Report date

2018-02-21

Termination date

2020-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gary, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0577-2018