Coloplast Recalls Pediatric Catheters Due to Missing Eyelets
Coloplast is voluntarily recalling a single lot of Self-Cath Pediatric Catheters because some units have missing eyelets, which can cause catheter malfunction.
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 medical device malfunction (missing eyelets) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Coloplast Manufacturing US, LLC is voluntarily recalling a single lot of Self-Cath Pediatric Catheters, French Size CH 06. The recall is based on a complaint received by the company regarding a catheter malfunction.
The recall was initiated because a small portion of the lot was identified to have missing eyelets. The affected product is a pediatric size CH06 French catheter indicated for use by patients with chronic urine retention and patients with a post void residual volume due to neurogenic and non-neurogenic voiding dysfunction.
The recall involves 31,320 units distributed nationwide in the states of AL, AR, C, FL, IL, KY, LA, MD, MA, MI, MN, MO, NJ, NY, NC, OK, OR, PA, TN, TX, VA, and WA. The specific lot code is 4464131. Consumers should stop using the affected catheters and contact Coloplast for instructions on how to return the product.
The recalled product
- Product
- Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine…
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- Affected units
- 31,320
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)
- 4464131
Distribution
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