Cure Medical Recalls Pediatric Urinary Catheters Due to Labeling Error
Cure Medical is recalling pediatric urinary catheters because some boxes are mislabeled as size 8 but contain size 10 catheters, posing a risk of injury.
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 where injury (urethral trauma, acute urinary retention) is a potential consequence of the labeling error, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Cure Medical LLC is recalling Pediatric, 10Fr, Intermittent Urinary Catheters, Model P10, Lot Number 140417-3. The recall involves 192 cases, which equates to 1,920 intermediate boxes and 57,600 individual catheters. The product is distributed nationwide.
The recall was initiated because some intermediate boxes within the affected lot were incorrectly labeled as P8 (French Size 8) pediatric catheters, but they actually contain P10 (French Size 10) catheters. The catheters are intended for bladder drainage in pediatric males and females.
Using a French Size 10 catheter when a French Size 8 catheter has been prescribed may result in acute urinary retention. Additionally, forced attempts to insert the larger French Size 10 catheter can lead to urethral trauma. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for instructions.
The recalled product
- Product
- Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual…
- Manufacturer
- Cure Medical LLC
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 (1)
- Lot Number: 140417-3
Distribution
Distributed nationwide across the United States.
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