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.
- Product Name: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold; BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Elbow Manifold
- Product Stock Codes:
- Distribution Dates: October 20, 2022 to January 23, 2023
- Devices Recalled in the U.S.: 1,000
- Date Initiated by Firm: February 22, 2023
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
Reason for Recall
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.
Who May be Affected
- Children, infants, or neonates who receive care using a BALLARD ACCESS Closed Suction Systems.
- Health care personnel providing care for pediatric or neonatal patients with a BALLARD ACCESS Closed Suction Systems.
What to Do
On February 3, 2023, Avanos Medical Inc. sent an Urgent Medical Device Recall letter to customers. The letter included the following recommended actions:
- Check all storage and usage locations for impacted BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold or with Elbow Manifold (labeled “72 hour use”).
- Quarantine all unused impacted product.
- Devices currently in use with patients.
- Check for cracks in manifold of any product currently in use with patients.
- Replace devices with cracked manifolds with a 24-hour use Ballard Closed Suction System for Neonates/Pediatrics (24-hour use products are unaffected by the reported issue).
- Use the 24-hour-use Ballard Closed Suction System for Neonates/Pediatrics for any new placements or scheduled placements.
- Complete and return the Acknowledgement Response Form included with the letter to FieldActioncare@avanos.com, with the subject line: FCA-2023-002 Hospital Acknowledgement Response Form.
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.
- Class 1 Device Recall: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold
- Class I Device Recall: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold
How do I report a problem?
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.