—#203239

Product

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

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K083641
Affected lot / code info: Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-08-22
Posted by FDA: 2023-10-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.