Recall Z-0205-2024 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD Inc.
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
| Date | Oct 31, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| 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 u |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083641 | BIVONA TRACHEOSTOMY TUBES Smiths Medical Asd, Inc., Feb 23, 2009 |