Recall Z-2485-2020 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD Inc.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
| Date | May 26, 2020 |
| Status | Terminated |
| Reason | One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate. |
| Root cause | Process control |
| Action | Smiths Medical sent a customer notification letter dated 05/18/2020, titled "Urgent Medical Device Recall Notice", to customers. The Recall Notice states that Smiths Medical has initiated a voluntary Medical Device Recall for one lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes (SKU 60HA30) that was packaged with a 3.5mm ID adjustable neck flange. The notice instructs customers to locate and quarantine the affected 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes by referring customers to the attached Urgent Medic |
| Quantity | 20 devices |
| Distribution | U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081440 | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES Smiths Medical Asd, Inc., Sep 12, 2008 |