Prodimed recalls pediatric catheters for blind bronchial sampling due to lack of sterility assurance. Affected units include COMBICATH PE 35 cm with product code 58 223 19. No remedy specified in recall notice.
Lack of assurance of sterility
Prodimed is recalling pediatric catheters used for blind bronchial sampling because they may not be sterile. This could lead to infections or other health risks if used improperly. The recall covers specific model numbers and all lots within their expiration dates.
The catheters lack proper sterility assurance, meaning they could become contaminated during production or handling. If used without proper sterilization, this could lead to infections or other complications in medical procedures.
Healthcare professionals and pediatric patients who use the COMBICATH PE 35 cm catheters for blind protected distal bronchial sampling are affected. Patients with medical conditions requiring these procedures are at higher risk.
Check for the product code 58 223 19 on the catheter packaging. The affected catheters are the COMBICATH PE 35 cm model used for blind protected distal bronchial sampling. All lots within the expiration date are included in this recall.
Look for the product code 58 223 19 on the catheter packaging to confirm if it is affected.
The recall is due to a lack of assurance of sterility, which could lead to contamination and infection risks during medical procedures.
The affected model is the COMBICATH PE 35 cm catheter with product code 58 223 19.
The recall notice does not specify a remedy, so there is no instruction to stop using or discard the product.
We’ve drafted a message you can send Prodimed to request your refund or repair — edit it as you like.
Subject: Recall Z-2492-2020 — Prodimed Prodimed Hello, I own a Prodimed that is covered by recall Z-2492-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
