Medline recalls non-sterile PVP solution kits (Model CDS980089O) that were mislabeled as sterile. This could lead to infection risks if used without proper sterilization.
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Medline is recalling non-sterile PVP solution kits (Model CDS980089O) that were incorrectly labeled as sterile. Using these kits without proper sterilization could lead to infections.
The kits were mislabeled as sterile when they are actually non-sterile. This means they cannot be used for sterile procedures without additional sterilization steps, increasing infection risk.
Healthcare professionals using these kits for ear procedures may be affected. Patients using the kits without proper sterilization could face infection risks.
Check for Model Number CDS980089O on the kit. Look for Lot Numbers 23EBE453 or 23CBW365. The kits were sold with UDI/DI codes 10195327303969 and 40195327303960.
Look for Model Number CDS980089O and Lot Numbers 23EBE453 or 23CBW365 on the kit.
The kits were mislabeled as sterile when they are actually non-sterile, which could lead to infection risks if used without proper sterilization.
Check for Model Number CDS980089O and Lot Numbers 23EBE453 or 23CBW365 on the kit.
The recall does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2132-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-2132-2023 from Medline. 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.
