Recall Z-1289-2025 ยท BTR Tube, Tracheal (W/Wo Connector)
Smiths Medical ASD, Inc.
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
| Date | Mar 12, 2025 (initiated Feb 13, 2025) |
| Status | Open, Classified |
| Reason | Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse. |
| Root cause | Process change control |
| Action | On February 13, 2025, the firm began to notify affected consignees via Urgent Medical Device Correction letters. Customers were informed that affected sizes of endotracheal tube products may have a smaller diameter than expected. Customers were instructed to check all inventory locations for affected products and discontinue use. Affected product should be destroyed following your institution's process for destruction. Product should be quarantined until disposal. All potential users of the device should be informed. If you have distributed affected product, please immediately forward the re |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790312 | ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR Respiratory Support Products, Inc., Feb 21, 1979 |