Z-3213-2017Class II

UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy...

Name: Z-3213-2017 UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy...
Creator: Smiths Medical ASD Inc.
Published: 2017-08-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-08-14 / Terminated

FDA source

Smiths Medical ASD Inc. began a recall of UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement... on 2017-08-14. FDA classified it as Class II and gives the reason as "Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3213-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-14
Posted: 2017-09-26
Terminated: 2019-06-18
Recalling firm: Abbott Medical
Product: UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
FDA root cause: Under Investigation by firm
Action: Smiths Medical sent an Urgent Medical Device Recall letter dated August 7, 2017. The consignees were directed to identify the recalled product, return it to Stericycle, and respond to the recalling firm within 10 days of receipt. For further questions, please call (763) 383-3000.
Quantity in commerce: 89 units
Distribution: INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
Product codes and lots: Lot number 3308971

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3213-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3213-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-26

Product code JOH

K962175Class IIPortex Adjustable Flange Tracheostomy TubeSmiths Industries Medical Systems, Inc. / cleared 1997-01-17

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)