Z-0205-2024Class II

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile

Name: Z-0205-2024 Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile
Creator: Smiths Medical ASD Inc.
Published: 2023-08-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-08-22 / Open, Classified / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile on 2023-08-22. FDA classified it as Class II and gives the reason as "The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0205-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-22
Posted: 2023-10-31
Recalling firm: Abbott Medical
Product: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 8/22/2023, a third-party recall notification service issued recall notifications to the direct accounts on behalf of the recalling firm via UPS ground. The letter explained the reason for the notification and embedded pictures of the incorrect and correct labels into the letter. The letter also provided the potential risk and required actions for users. The potential risk involves the potential for a customer to assess the product as expired, resulting in the potential for a delay in the availability to use the tracheostomy device. If the customer did not identify the incorrect device unit carton/secondary packaging labeling upon receipt and provided the items to clinicians, the individual device tray/primary packaging would still allow correct identification of the expiration date at the point of use, as the expiry date on the individual unit is correctly labeled. The required actions included (1) informing potential users within their organization of the notification and to complete and return the attached response form via email within ten days of receipt to acknowledge if they have the affected product and/or if it has already been used; and (2) if the account has further distributed the product, immediately notify those customers of the field correction. The letter instructs that if the product has not already been used, the product must be used before the correct expiry of March 17, 2026.
Distribution: Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.
Product codes and lots: Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0205-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0205-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-31

Product code JOH

K083641Class IIBivona Tracheostomy TubesSmiths Medical Asd, Inc. / cleared 2009-02-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)