Class 2 Device Recall Portex Bivona

• Date Initiated by Firm: August 22, 2023
• Date Posted: October 31, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0205-2024
• Recall Event ID: 92996
• 510(K)Number: K083641
• Product Classification: Tube tracheostomy and tube cuff - Product Code JOH
• Product: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Code Information: Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: Tom McCall; 949-366-4368
• Manufacturer 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).
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JOH and Original Applicant = SMITHS MEDICAL ASD, INC.