Prodimed recalls Combicath catheters for blind or fibrescope-guided bronchial sampling due to lack of sterility assurance. Affected units include specific model and lots. Consumers should contact Prodimed for details.
Lack of assurance of sterility
Prodimed is recalling Combicath catheters used for bronchial sampling because they may not be sterile. This could lead to infections if used improperly. The recall covers specific model numbers and production lots.
The catheters lack assurance of sterility, meaning they might not be clean enough to prevent infections during medical procedures. This risk is particularly concerning for procedures involving the respiratory system where contamination could lead to serious complications.
Healthcare professionals using the Combicath catheters for bronchial sampling procedures are most at risk. Patients receiving these procedures may also be affected if the catheters are not sterile.
Check for the model name 'COMBICATH PE 90 cm' and product code 58229 19 on the catheter packaging. The recall includes all lots within the expiry date.
Reach out to Prodimed for specific instructions on how to return or replace the catheters.
The catheters lack assurance of sterility, which could lead to infections during medical procedures.
The affected model is Combicath PE 90 cm with product code 58229 19.
Look for the model name 'COMBICATH PE 90 cm' and product code 58229 19 on the packaging.
We’ve drafted a message you can send Prodimed to request your refund or repair — edit it as you like.
Subject: Recall Z-2490-2020 — Prodimed Prodimed Hello, I own a Prodimed that is covered by recall Z-2490-2020 from Prodimed. 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.
