Prodimed recalls Combicath catheters for mini bronchoalveolar lavage due to lack of sterility assurance. Affected units include specific product codes and all lots within expiry dates.
Lack of assurance of sterility
Prodimed is recalling Combicath catheters used for mini bronchoalveolar lavage because they may not be sterile. This could lead to infections if used improperly. Affected units have specific product codes and expiry dates.
The catheters may not be sterile, which can lead to infections if used in medical procedures. This is a risk during mini bronchoalveolar lavage treatments where the catheters are inserted into the lungs.
Healthcare professionals using these catheters for medical procedures are most at risk. Patients receiving the catheters during procedures could be affected if the catheters are not sterile.
Check for the product code 58216 27US on the catheter packaging. The recall includes all lots within the expiry date.
Look for the product code 58216 27US on the catheter packaging.
The catheters may not be sterile, which can lead to infections during medical procedures.
Product code 58216 27US.
The recall does not specify a stop-use instruction; check the product code to see if it is affected.
We’ve drafted a message you can send Prodimed to request your refund or repair — edit it as you like.
Subject: Recall Z-2487-2020 — Prodimed Prodimed Hello, I own a Prodimed that is covered by recall Z-2487-2020 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.