ConvaTec Recalls Nelaton Urinary Catheters Due to Sterile Barrier Breach Risk
ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a breach in the sterile barrier could lead to infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
ConvaTec, Inc. is recalling Nelaton Urinary Catheters, which are sterile, disposable devices intended for intermittent drainage of fluids from the bladder. The recall involves 5,744,525 units labeled as CH16/40CM and CH14/40CM, with product codes 505599 and 505603, and lot codes 222348 and 222349.
The recall was initiated after an internal assessment of the packaging confirmed the potential for a breach in the sterile barrier. This defect could compromise the sterility of the catheters, which are designed for single use to prevent urinary tract infections.
The affected products were distributed worldwide, including in the United States (Illinois, Michigan, Pennsylvania, and Wisconsin) and numerous international countries. Consumers and healthcare providers should stop using these specific lots and contact ConvaTec for further instructions or a return.
The recalled product
- Product
- Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are…
- Manufacturer
- ConvaTec, Inc
- Affected units
- 5,744,525
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Codes/REF Numbers: 505599
- 505603
- Lot Codes: 222348
- 222349
Distribution
Part of a larger recall action
This product is one of 4 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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