Coloplast recalls X-Flow prostatectomy catheters with specific device reference numbers and lot numbers due to a possible sterility issue detected in their facility.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Coloplast is recalling certain X-Flow prostatectomy catheters that were manufactured with a possible sterility issue. This could lead to infection if the catheter is used without proper sterilization.
The recall is based on a possible sterility issue detected in Coloplast's facility. This means the catheters might not be properly sterilized, increasing the risk of infection if used in medical procedures.
Patients who have been prescribed or received these specific X-Flow prostatectomy catheters are likely affected. Healthcare providers using these catheters for surgical procedures may also be at risk.
Check the device reference numbers (AB6022, AB6024, etc.) and lot numbers listed in the recall notice. These catheters were sold with specific GTINs and lot numbers as detailed in the recall.
Review the device reference numbers and lot numbers on your catheter to determine if it is recalled.
Coloplast detected a possible sterility issue in their facility for some products, which could lead to infection if the catheter is not properly sterilized.
Check the device reference numbers and lot numbers on your catheter against the list provided in the recall notice.
Contact Coloplast directly to confirm if your catheter is affected and follow their instructions for next steps.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-0845-2025 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-0845-2025 from Coloplast. 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.
