Avanos Medical recalls its Ballard Access Closed Suction System Y-Manifold for neonates/pediatrics due to potential manifold cracking during use, which could lead to inadequate patient ventilation. All affected lots are listed in the recall notice.
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 Y-Manifold for neonates and pediatrics because the manifold may crack during use, potentially causing leaks in the respiratory circuit and inadequate ventilation for patients. This poses a serious risk to infants and children who require this medical equipment.
The Y-manifold in the suction system may crack during use, which can cause leaks in the respiratory circuit. This could result in the patient receiving inadequate ventilation, potentially leading to serious health complications or harm.
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 inadequate ventilation.
Check for the stock code (lot number) listed: B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), or B31011 (20098363). The product is used for neonates and pediatric patients in medical settings.
Immediately stop using the Ballard Access Closed Suction System Y-Manifold if it has the listed stock codes (B30511 to B31011).
The recalled product is the Ballard Access Closed Suction System Y-Manifold for neonates and pediatrics.
All lots with stock codes B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), and B31011 (20098363) are affected.
The recall notice does not mention a fix or replacement; the remedy is null.
We’ve drafted a message you can send Avanos Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1189-2023 — Avanos Medical Avanos Medical Hello, I own a Avanos Medical that is covered by recall Z-1189-2023 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.
