Convatec Recalls Latex Foley Catheters Due to Blocked Lumen
Convatec Inc. is recalling Curion CuriStay Nelaton latex Foley catheters because the drainage lumen was found blocked by excess lubricious coating material.
What this means for you
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 is classified as FDA Class II. The hazard involves a functional defect (blocked lumen) in a medical device that could lead to harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Convatec Inc. is recalling 3,840 units of Curion CuriStay Nelaton CH-14 2-W Hydrogel Coated (Latex) Foley catheters. The recall is due to a defect where the catheter's lumen was found to be blocked by excess lubricious coating material.
The affected product is a latex lubricous coated Foley catheter used for urinary drainage. The standard catheter consists of a flexible tube with one major drainage lumen and one or two minor lumens for balloon inflation or irrigation. The blockage in the drainage lumen prevents the device from functioning as intended.
The recall number is Z-1237-2014, and the specific code is 540204R001. The product was distributed worldwide and in the state of Texas. Users should stop using the affected catheters and contact Convatec Inc. for further instructions.
The recalled product
- Product
- Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL 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 minor
- Manufacturer
- Convatec Inc.
- Category
- Medical Device — Foley Catheter
- Affected units
- 3,840
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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