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
FDA device recall Z-1289-2025 · posted 2025-03-12 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- 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.
- Action taken
- 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 recall notice to your customers.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- BTR
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2025-02-13
- Date posted
- 2025-03-12
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR (K790312) | Respiratory Support Products, Inc. | 1979-02-21 |