Prodimed recalls Combicath catheters for mini bronchoalve: Lavage (BAL) due to lack of sterility assurance. All units within expiry date are affected.
Lack of assurance of sterility
Prodimed is recalling Combicath catheters used for mini bronchoalveolar lavage (BAL) because they may not be sterile. This could lead to infections if used improperly.
The catheters lack assurance of sterility, meaning they might not be clean enough for medical use. This could cause infections in patients during procedures.
Healthcare professionals using the catheters for BAL procedures are most at risk. Patients receiving these catheters could face infection if the device isn't sterile.
Check for the model 'COMBICATH PE 85 cm x 4.0 mm' with lot number 58124 and serial number 40US. All units within the expiry date are affected.
Verify the model number and lot/serial numbers to confirm if your catheter is affected.
The recall states there is a lack of sterility assurance, so they are not safe for medical use.
Check for the model 'COMBICATH PE 85 cm x 4.0 mm' with lot number 58124 and serial number 40US.
The recall does not specify a remedy, so contact Prodimed for guidance.
We’ve drafted a message you can send Prodimed to request your refund or repair — edit it as you like.
Subject: Recall Z-2488-2020 — Prodimed Prodimed Hello, I own a Prodimed that is covered by recall Z-2488-2020 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.
