Avanos Medical recalls Ballard Closed Suction Catheters model 210 due to lack of sterility assurance. This poses infection risks for neonatal and pediatric patients. Affected units include specific lot numbers.
Lack of sterility assurance for closed suction catheter systems
Avanos Medical recalls Ballard Closed S:uction Catheters model 210 because they lack sterility assurance. This means the catheters could cause infections in newborns and children during medical procedures. The recall affects specific lot numbers sold to hospitals and clinics.
The catheters lack proper sterility assurance, meaning they may not be clean enough to prevent infections. This is a risk during medical procedures where the catheters are inserted into a patient's body. Infections can occur if the catheters are not sterile.
Hospitals and clinics using Ballard Closed Suction Catheters model 210 for neonatal and pediatric patients are affected. The highest risk is for infants and children receiving medical care with these catheters.
Check for the model number 210 on the Ballard Closed Suction Catheters. Look for lot numbers 1561165, 00609038938349, 10609038938346, or 20609038938343 on the packaging or labels.
Identify the lot number on the catheter packaging or label to confirm if it is affected.
The Ballard Closed Suction Catheters model 210 lack sterility assurance, which could lead to infections in neonatal and pediatric patients during medical procedures.
Check the lot number on the packaging or label. If it matches the affected numbers (1561165, 00609038938349, 10609038938346, or 20609038938343), contact Avanos Medical for guidance.
The recall does not provide a fix; affected units should be checked and contacted for further instructions.
We’ve drafted a message you can send Ballard to request your refund or repair — edit it as you like.
Subject: Recall Z-1522-2025 — Ballard Ballard Hello, I own a Ballard that is covered by recall Z-1522-2025 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.
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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.