Avanos Medical recalls Ballard Closed Suction Catheters model 220135 due to lack of sterility assurance. Affected units may cause infections if used without proper sterilization.
Lack of sterility assurance for closed suction catheter systems
Avanos Medical recalls Ballard Closed Suction Catheters model 220135 because they lack sterility assurance. Using these catheters without proper sterilization could lead to infections.
The catheters do not have adequate sterility assurance, meaning they may not be properly sterilized before use. This can lead to infections if used without proper sterilization procedures.
Adults using Ballard Closed Suction Catheters model 220135 for medical purposes. Healthcare providers and patients using these catheters are most at risk.
Check for model number 220135 on the catheter packaging or label. Lot numbers 1555453 and 1564227 are also associated with this recall.
Verify if the catheters have been properly sterilized before use.
The recall states there is a lack of sterility assurance, so they may not be safe without proper sterilization.
The recall does not specify a remedy, so check with your healthcare provider for proper sterilization procedures.
Affected units have model number 220135 and lot numbers 1555453 or 1564227.
We’ve drafted a message you can send Ballard to request your refund or repair — edit it as you like.
Subject: Recall Z-1524-2025 — Ballard Ballard Hello, I own a Ballard that is covered by recall Z-1524-2025 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.