Z-1993-2021Class II

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 -

Name: Z-1993-2021 PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 -
Creator: Smiths Medical ASD Inc.
Published: 2021-05-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-05-14 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care... on 2021-05-14. FDA classified it as Class II and gives the reason as "One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1993-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-14
Posted: 2021-07-01
Terminated: 2023-06-09
Recalling firm: Abbott Medical
Product: PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm initiated the recall by email on 05/14/2021. The notice requested the return of the units and distributors were directed to notify their customers.
Quantity in commerce: 40 units
Distribution: US Nationwide distribution in the states of PA, MI, MD, FL.
Product codes and lots: Lot Number 4072715

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1993-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1993-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-07-01

Product code JOH

K041348Class IIPortex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line UltraSmiths Medical / cleared 2004-07-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)