Z-0726-2021Class II

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

Name: Z-0726-2021 PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Creator: Smiths Medical ASD Inc.
Published: 2020-12-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-12-15 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD Inc. began a recall of PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 on 2020-12-15. FDA classified it as Class II and gives the reason as "A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0726-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-15
Posted: 2020-12-28
Terminated: 2022-12-20
Recalling firm: Abbott Medical
Product: PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm initiated the recall by letter on 12/15/2020. The letter requested the following: "INSTRUCTIONS TO CUSTOMERS AND DISTRIBUTORS: 1. Locate affected product in your possession by referring to the Affected Devices List (Table 1) listed on this Recall Notice. 2. Determine the number of affected devices in your possession and complete the Response Form (Attachment 1) within 10 days of receipt, returning it to [email protected]. The form must be returned even if you do not have any affected Bivona Cuffless FlexTend Tracheostomy Tube Devices in your possession. 3. All affected product must be returned to Smiths Medical for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. When returning product please include a copy of the Response Form (Attachment 1) inside EACH BOX. 4. Product credit will be processed once the impacted product and Response Form (Attachment 1) has been received and processed. 5. DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall with the editable Response Form for your customers (Attachment 1a) to respond appropriately."
Quantity in commerce: 238 devices
Distribution: US nationwide distribution.
Product codes and lots: Lot Number 3991195

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0726-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-28

Product code JOH

K944178Class IIBivona Flextend Pediatric & Neonatal Tracheostromy TubesBivona Medical Technologies / cleared 1994-10-27

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)