ConvaTec recalls Nelaton urinary catheters with potential sterile packaging breach. These disposable catheters may risk infection if not properly sealed. Consumers should check labels for CH16/40CM or CH14/40CM models.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
ConvaTec is recalling Nelaton urinary catheters that may have packaging breaches risking infection. This affects specific models sold with labels CH16/40CM or CH14/40CM. The recall is due to potential contamination from compromised sterile packaging.
The sterile packaging could be breached, allowing contamination. This might lead to urinary tract infections if the catheter is not properly sealed. The risk is low as the catheters are designed for single use.
People using urinary catheters for temporary bladder drainage may be affected. Those with medical conditions requiring catheter use are most at risk.
Check for labels marked CH16/40CM or CH14/40CM on the catheter packaging. These models were sold with specific lot codes 222348 or 222349.
Look for labels indicating CH16/40CM or CH14/40CM on the catheter packaging.
The recall is due to potential breaches in the sterile packaging that could lead to contamination.
Models labeled CH16/40CM and CH14/40CM with lot codes 222348 or 222349.
The recall does not require immediate stop-use; however, check for packaging issues before use.
We’ve drafted a message you can send ConvaTec to request your refund or repair — edit it as you like.
Subject: Recall Z-1037-2019 — ConvaTec ConvaTec Hello, I own a ConvaTec that is covered by recall Z-1037-2019 from ConvaTec. 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.
