Convatec SLC Foley Catheters Recalled for Blocked Lumens
Convatec Inc. is recalling 5,540 SLC 2-way Foley catheters because excess lubricious coating material was found blocking the lumen.
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 is classified as FDA Class II. The defect (blocked lumen) poses a risk of harm to patients, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Convatec Inc. is recalling 5,540 units of SLC 2-way standard Lubricious Coated Foley Catheters. The recall was initiated because the lumen of the catheter was found to be blocked by excess lubricious coating material.
The affected product is a latex lubricous coated Foley catheter used for drainage and balloon inflation. The recall covers units distributed worldwide and in the state of Texas. The specific code for the affected units is 540204R001.
Consumers and healthcare providers should stop using the affected catheters and contact Convatec Inc. for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: 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 lumens…
- Manufacturer
- Convatec Inc.
- Category
- Medical Device — Catheters
- Affected units
- 5,540
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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