Z-0577-2018Class II

Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a...

Name: Z-0577-2018 Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a...
Creator: Smiths Medical ASD, Inc.
Published: 2016-07-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-07-15 / Terminated / root cause: sterility

FDA source

Smiths Medical ASD, Inc. began a recall of 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... on 2016-07-15. FDA classified it as Class II and gives the reason as "Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0577-2018
Classification: Class II
Status: Terminated
Initiated: 2016-07-15
Posted: 2018-02-09
Terminated: 2020-04-24
Recalling firm: Abbott Medical
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.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm, Smith Medical, notified the consignee by phone on July 29, 2017 of the Field Corrective Action Report. The consignee was instructed to return the devices for destruction and replacement. If you have any questions, contact VP, Global Quality and Regulatory at 219-989-9150.
Quantity in commerce: 1
Distribution: International Distribution to:Germany
Product codes and lots: GS025081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0577-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0577-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09

Product code JOH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)