Coloplast recalls ureteral dilator products REF RBD014 with possible sterility packaging breaches. Affected units have specific lot codes; contact for remedy.
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Coloplast is recalling ureteral dilators with lot codes listed in the record due to a possible breach in sterile packaging. This could lead to infection risks if the product is used without proper sterility.
A possible breach in the sterile packaging could allow contamination. If the product is not sterile, it might cause infections during medical procedures.
Patients using ureteral dilators for medical procedures may be affected. Medical professionals handling these products are most at risk due to potential sterility issues.
Check for lot codes 6885096 through 9360599 on the packaging. The product is identified as Ureteral dilator REF RBD014.
Look for lot codes listed in the recall: 6885096, 6928493, 7036982, and other specific numbers.
The recall states a possible sterility packaging issue was detected, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Coloplast directly for guidance.
Check the lot code on the packaging against the list provided: 6885096, 6928493, 7036982, and other specific numbers.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1463-2024 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1463-2024 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.
