Recall Z-0146-2025 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Smiths Medical ASD Inc.
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
| Date | Oct 23, 2024 (initiated Jul 18, 2024) |
| Status | Open, Classified |
| Reason | Uncertainty in the seal integrity of the sterile packaging. |
| Root cause | Packaging process control |
| Action | Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed. Distributors were directed to notify their customers by forwarding the notice. Questions - contact smithsmedical.@sedgwick.com. |
| Quantity | 27,971 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.