Recall Z-1390-2025 ยท JOH Tube Tracheostomy And Tube Cuff
Covidien
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
| Date | Mar 25, 2025 (initiated Feb 26, 2025) |
| Status | Open, Classified |
| Reason | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death. |
| Root cause | Under Investigation by firm |
| Action | On 2/26/2025, recall notices were mailed and/or emailed to Risk Managers, Directors of Respiratory Care, Anesthesiology, Pulmonary/Intensive Care and ENT who were asked to do the following: 1) For patients with affected devices currently in place, a replacement is required. The patient's medical team should assess the overall patient risk when considering the timing of replacement. Clinicians should continue to follow current product Instructions For Use (IFU) along with facility specific policies and procedures. 2) Quarantine and return all unused product from the affected lot in your inv |
| Quantity | 780 |
| Distribution | OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with T Covidien, Jul 14, 2015 |