The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The manifold of the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics is used to provide access to the artificial airway of a child, infant, or neonate, without breaking the ventilation circuit. It is a single patient use device that is used by trained medical professionals.

The BALLARD ACCESS Closed Suction manifold is indicated for use together with the BALLARD ACCESS Closed Suction catheter to remove secretions from the artificial airway of children, infants, and neonates

Avanos Medical Inc. is recalling the Avanos BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold or Elbow Manifold (labeled 72-hour-use) after receiving complaints from customers about cracked manifolds during use. A cracked manifold can cause leaks in the respiratory circuit, which may lead to the patient receiving inadequate ventilation.

Inadequate ventilation and oxygenation can lead to lead serious brain damage or death, especially in the vulnerable patient population (children, infants, and neonates) who receive care using this product. Additional risks from this issue include the possibility that a foreign body could be introduced through the cracked manifold, causing infection, damage to the airway, or a blocked endotracheal tube.

Use of this product could lead to serious injury or death.

Avanos Medical, Inc. reports four injuries associated with this issue.

On February 3, 2023, Avanos Medical Inc. sent an Urgent Medical Device Recall letter to customers. The letter included the following recommended actions:

Customers will be contacted by Avanos Customer Service to arrange for product return, credit, and replacement after the acknowledgement form is submitted.

Customers with questions about this recall should email Avanos at FieldActionCare@avanos.com.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

05/02/2023

See the article here:

Avanos Recalls Certain BALLARD ACCESS Closed Suction Systems - FDA.gov