Neonatal, Pediatric Intubation Kit Recall Issued by Medline Industries Following Multiple Injuries: FDA

Manufacturer recommends discontinuing the use of certain kits for intubation, due to undersized endotracheal tubes, which could pose serious health risks.

Federal health officials have announced a Class I recall affecting certain Medline neonatal and pediatric kits containing Smiths Medical ORAL/NASAL endotracheal tubes.

The Medline Industries neonatal and pediatric kit recall was announced by the U.S. Food and Drug Administration (FDA) on June 17, following at least eight reports of injuries due to underventilation. 

Medtronic neonatal and pediatric convenience kits are used for various medical procedures, including intubation. The kits include Smiths Medical ORAL/NASAL endotracheal tubes, which help maintain open airways and support ventilation by being inserted through the mouth or nose during intubation.

However, officials warn that the tubes have a smaller-than-expected diameter, which may prevent patients from receiving adequate ventilation. This can result in serious health consequences, including oxygen deprivation, laryngeal swelling, organ failure, cardiopulmonary arrest and even death.

While no deaths have been reported, the FDA has categorized this action as a Class I recall, the most severe type, indicating that continued use of the affected devices could result in life-threatening complications. 

The recall impacts the following products with corresponding Unique Device Identifier (UDI) numbers:

• Neonatal Intubation Tray, UDI: 10193489268188
• Newborn Resuscitation Kit, UDI: 10193489800944, 10193489457803, 10193489922127
• Peds Grey-Pink-Red, UDI: 10193489218152
• Peds Purple, UDI: 10193489218169
• Neonatal Intubation Tray, UDI: 10195327036980, 10195327153649, 10198459155765
• Pediatrics Intubation Tray, UDI: 10193489297980

Healthcare providers are being instructed to check their inventory and discontinue use of the recalled products. All recalled kits should be destroyed, and any customers who may have received the affected products should be notified and advised to do the same.

The destruction form included with the notification letter should be returned regardless of whether the products are in inventory. Once the form is completed, Medline Industries will issue a credit.

Customers with questions can contact Medline Industries at 866-359-1704 or email Recalls@Medline.com.

Any adverse reactions or quality problems experienced while using these devices can also be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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