Recall Z-0528-2025 ยท BSR Stylet, Tracheal Tube
Smiths Medical ASD, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
| Date | Nov 25, 2024 (initiated Oct 28, 2024) |
| Status | Open, Classified |
| Reason | Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device. |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 10/28/2024, mailed using a traceable means. The notice explained the issue, potential risk, and requested the consignee locate and destroy all affected products, and distribute the notice to all affected parties. Distributors were directed to notify their customers. For questions: About the communication: smithsmedical7602@sedgwick.com, 1-800-913-3897; To report adverse events: globalcomplaints@icumed.com, 1-866-216-8806 |
| Quantity | 10,223 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.