Convatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen
Convatec Inc. is recalling 54,590 Toray Hydrocoat Foley Catheters because the drainage lumen was found to be 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 FDA classified this as a Class II recall. The hazard involves a blocked lumen in a medical device, which poses a risk of harm (inability to drain urine) but the source does not report specific injuries or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Convatec Inc. is recalling 54,590 units of the 'TORAY' Hydrocoat Foley Catheter (12 x10, 4.00 mm Fr). The recall was initiated because the lumen of the catheter was found to be blocked by excess lubricious coating material. The product is a latex lubricous coated Foley catheter used for drainage and bladder irrigation.
The affected catheters were distributed worldwide and in the state of Texas. The specific lot code associated with this recall is 540204R001. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected catheters and contact Convatec Inc. for instructions on return or replacement. No specific instructions for consumer action are provided in the source text beyond the standard recall notification.
The recalled product
- Product
- 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x 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 lumens construc
- Manufacturer
- Convatec Inc.
- Category
- Medical Device — Foley Catheter
- Affected units
- 54,590
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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