Medline Sterile Foley Catheter Recalled for Blocked Lumen
Convatec Inc. is recalling Medline Sterile Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.
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 with a functional defect (blocked lumen) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Convatec Inc. is recalling Medline Sterile Foley Catheters, model number DNYD11914. The recall involves 600 catheters that were distributed worldwide and in the state of Texas.
The recall was initiated because the lumen of the catheter was found to be blocked by excess lubricious coating material. This defect could prevent the catheter from functioning as intended for drainage.
Consumers who have these specific catheters should stop using them and contact Convatec Inc. for instructions on how to return the product.
The recalled product
- Product
- Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two…
- Manufacturer
- Convatec Inc.
- Category
- Medical Device — Foley Catheter
- Affected units
- 600
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)
- 540204R001
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 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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