Smiths Medical ASD Inc.: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Recall number

Z-0205-2024

Recalling firm

Smiths Medical ASD Inc.

Product

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

Status

Open, Classified

Initiated

2023-08-22

Posted

2023-10-31

Terminated

not on file

Reason

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

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.

Quantity

not on file

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.

Lot, serial or model codes

Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

510(k) numbers

["K083641"]

PMA numbers

not on file

Product code

JOH

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy