Dive Brief:
- Medline has asked hospitals to remove thousands of endotracheal tubes because of a risk that components can tear or detach, blocking a patient’s airway.
- The company recalled more than 168,000 Medline Sub-G Endotracheal Tubes and more than 13,000 kits, according to a Food and Drug Administration notice posted on May 28. The tubes are used for mechanical ventilation and have ports to prevent fluid from draining into patients’ lungs and causing pneumonia.
- Medline recalled the products because the inflation tube and other components can detach or tear from the main tube, causing it to leak or deflate. If the device comes apart during use, it could also obstruct the patient’s airway or cause choking, the FDA said in a Tuesday notice.
Dive Insight:
Medline asked hospitals to immediately check their stock for recalled endotracheal tubes and destroy them. Use of the affected tubes can cause serious health problems, including low oxygen, unplanned removal of a breathing tube, respiratory distress, ventilator associated pneumonia, cardiac arrest, brain anoxia or death, the FDA said.
The agency has received three reports of injuries and no reports of death associated with the recall. In a May 31 announcement, Medline said it was “not aware of any serious health consequences which have occurred due to use of the device.” A company spokesperson did not answer whether the company had received any reports of related injuries or deaths.
Medline has recently come under scrutiny amid the FDA’s crackdown on plastic syringes made in China and distributed in the U.S. In April, Medline recalled plastic syringes made in China because they had different characteristics than FDA-authorized syringes and because of performance testing failures. Medline told customers to destroy the affected devices.
The FDA sent Medline a warning letter for selling and distributing the syringes and for quality system violations.
Last month, the company also recalled about 1.5 million adult bed rails in conjunction with the Consumer Product Safety Commission because of the risk of entrapment and asphyxia. Medline received two reports of death related to the bed assist bars.
