Prodimed recalls Combicath catheters for blind or fibrescope-guided bronchial sampling due to lack of sterility assurance. Affected units include specific model and all lots within expiry.
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. Affected units have a specific product code and expiry dates.
The catheters lack assurance of sterility, meaning they might not be clean enough to prevent infections during medical procedures. This risk is specific to the procedure where the catheters are used for bronchial sampling.
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 product code 58229 19US on the Combicath catheters. The catheters are 90 cm long and 1.9 mm in diameter. All lots within the expiry date are affected.
Look for product code 58229 19US on the Combicath catheters.
Yes, the product code is 58229 19US for the Combicath catheters.
The catheters lack assurance of sterility, which could lead to infections during medical procedures.
Check for the product code 58229 19US and the catheters' length (90 cm) and diameter (1.9 mm).
We’ve drafted a message you can send Prodimed to request your refund or repair — edit it as you like.
Subject: Recall Z-2489-2020 — Prodimed Prodimed Hello, I own a Prodimed that is covered by recall Z-2489-2020 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.
