Overview: Medline Industries, LP has initiated a recall of its Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to serious defects. The FDA has classified this recall as the most severe, indicating that continued use of these devices could result in serious injury or death.
Affected Products:
- Product Names: Medline Sub-G Endotracheal Tube with Subglottic Suctioning
- Models: Includes 6 Sub-G Endotracheal Tubes and 10 kits containing these devices
- Lot/Serial Numbers: All lots from the specified series
Action Required:
- Check Inventory: Immediately identify and remove any affected items.
- Destroy Affected Products: Dispose of any defective inventory.
- Notification: Medline issued a recall notice on February 26, 2024, instructing customers to:
- Complete and return the response form.
- List affected products and quantities.
- Share the recall notice with others who might have received the product.
- Document and destroy any affected items.
Reason for Recall: The recall was prompted by the detachment or tearing of the inflation tube and other components from the main tube, leading to cuff leakage, deflation, moisture buildup, and failure to inflate. These defects can cause severe health issues such as:
- Airway obstruction or choking
- Hypoxemia (low oxygen levels)
- Forced extubation (unplanned removal of the tube)
- Re-intubation (need to insert a new tube)
- Ventilator-associated pneumonia
- Respiratory distress and acidosis (carbon dioxide buildup)
- Cardiac arrest
- Brain anoxia (no oxygen to the brain)
- Tissue and organ damage
- Death
Reported Incidents: The FDA has received three injury reports related to these devices but no reports of death.
Device Use: The Sub-G Endotracheal Tube is designed to assist patients in breathing by being inserted through the mouth into the windpipe, helping to keep the airway open and allowing for oxygen, medicine, or anesthesia administration. It is typically used for patients with conditions such as pneumonia, emphysema, heart failure, a collapsed lung, or severe injuries.
This recall highlights the critical importance of using only safe and reliable medical devices, emphasizing the potential risks and necessary actions to protect patient health.
For Further Action: If you possess any affected products or need more information, contact Medline Industries directly and ensure all recalled devices are promptly disposed of to prevent any health risks