Avanos Medical recalls Ballard Closed Suction Catheters model 198 due to lack of sterility assurance. This poses a risk of infection during medical procedures for neonates and pediatrics. Affected units have specific lot numbers and serial codes.
Lack of sterility assurance for closed suction catheter systems
Avanos Medical recalls Ballard Closed S:198 suction catheters because they lack sterility assurance. This means the catheters could cause infections during medical procedures for newborns and children. Affected units have specific lot and serial numbers.
The catheters lack sterility assurance, meaning they may not be clean enough to prevent infections during medical procedures. This is a risk in neonatal and pediatric care where infections can be serious.
Healthcare providers using the Ballard Closed Suction Catheters model 198 for neonatal and pediatric care. Newborns and infants are at higher risk due to the medical use.
Check for model number 198 on the Ballard Closed Suction Catheters. Affected units have specific lot numbers like 1561168 and serial numbers such as 00609038938264.
Look for model number 198, lot numbers starting with 1561168, and serial numbers like 006:09038938264 on the catheters.
The Ballard Closed Suction Catheters model 198 lack sterility assurance, which could lead to infections during medical procedures for newborns and children.
Check for model number 198, lot numbers starting with 1561168, and serial numbers like 00609038938264 on the catheters.
The recall record does not specify a remedy, so contact Avanos Medical for guidance.
We’ve drafted a message you can send Ballard to request your refund or repair — edit it as you like.
Subject: Recall Z-1521-2025 — Ballard Ballard Hello, I own a Ballard that is covered by recall Z-1521-2025 from Ballard. 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.
