Avanos Medical recalls its Ballard Access Closed Suction System elbow manifold for neonates/pediatrics due to potential cracking during use, which could cause leaks and inadequate ventilation. Affected units include specific lot numbers from 2009.
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Avanos Medical is recalling its Ballard Access Closed Suction System elbow manifold for neonates and pediatrics because it can crack during use, potentially causing leaks in the respiratory circuit and leading to inadequate ventilation for patients. This is a serious risk for infants and children in medical settings.
The elbow manifold in the suction system can crack during use, which may cause leaks in the respiratory circuit. If leaks occur, patients could receive inadequate ventilation, leading to serious health risks such as respiratory distress or failure.
Healthcare providers using the Ballard Access Closed Suction System for neonates and pediatric patients are affected. Infants and children receiving this equipment are at the highest risk due to the potential for leaks and inadequate ventilation.
Check for the specific lot numbers: B50511 (20098277), B50611 (20098278), B50711 (20098279), or B50811 (20097177, 20097177R1). The product is sold for neonatal and pediatric use.
Immediately stop using the affected Ballard Access Closed Suction System elbow manifold as it can crack during use, potentially causing leaks and inadequate ventilation.
Affected lot numbers include B50511 (20098277), B50611 (20098278), B50711 (20098279), and B50811 (20097177, 20097177R1).
The elbow manifold can crack during use, potentially causing leaks in the respiratory circuit and leading to inadequate ventilation for patients.
The recall record does not mention any remedy or replacement options.
We’ve drafted a message you can send Avanos Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1190-2023 — Avanos Medical Avanos Medical Hello, I own a Avanos Medical that is covered by recall Z-1190-2023 from Avanos Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
