FDA recalls pediatric breathing kits after eight serious injuries
The U.S. Food and Drug Administration (FDA) has issued a recall of a line of neonatal and pediatric convenience kits, distributed by Medline, after eight injuries to infant patients. The kits contain endotracheal tubes manufactured by Smiths Medical that are too small and may prevent babies from breathing properly.
The kits are used in clinical settings to provide emergency intubation through the mouth or nose, in the event a newborn needs help to maintain an open airway. They are also used during non-emergency medical procedures to support ventilation.
There have been no reported deaths. However, due to the high risk of hypoxia, organ failure, cardiac arrest and other serious complications associated with limited respiration, the recall has been designated a Class I, the most serious type.
All products subject to the recall must not be used and must be destroyed immediately to ensure patient safety.
What is being recalled?
Medline and the FDA provided a complete list of recalled kits, including identifying information from all affected lots.
| Product Name | Product Code | UDI |
|---|---|---|
| NEONATAL INTUBATION TRAY | ACC010371C | 10193489268188 |
| NEWBORN RESUSCITATION KIT | ACC010381A | 10193489800944 |
| NEWBORN RESUSCITATION KIT | ACC010381B | 10193489457803 |
| NEWBORN RESUSCITATION KIT | ACC010381C | 10193489922127 |
| PEDS GREY-PINK-RED | ACC010395 | 10193489218152 |
| PEDS PURPLE | ACC010397 | 10193489218169 |
| NEONATAL INTUBATION TRAY, | ACC010541A | 10195327036980 |
| NEONATAL INTUBATION TRAY | ACC010541B | 10195327153649 |
| NEONATAL INTUBATION TRAY | ACC010541C | 10198459155765 |
| PEDIATRICS INTUBATION TRAY | DYNJAA252 | 10193489297980 |
Next steps
Medline said it alerted all known customers to the defect on April 4. In the company’s letter, it instructed all clinicians and supply houses to isolate and stop using recalled kits immediately.
All of the relevant kits are to be destroyed immediately, and customers are asked to return a form confirming they’ve been properly discarded. The form asks for details, such as product quantities, which Medline added are important to include, as it will help with ensuring all dangerous products are eliminated from supply.
This is also how refunds will be distributed. Customers in the U.S. are invited to contact Medline at 866-359-1704 or [email protected] for more details.
Both the company and the FDA ask that the recall notice be shared. It can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.