Agency classClass IIOur severity:High FDA (Devices)·Z-1241-2014·Announced 2014-03-26

Convatec Latex Foley Catheters Recalled Due to Blocked Lumen

Convatec Inc. is recalling 4,760 SLC 3-way standard latex 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 is classified as FDA Class II. The hazard involves a functional defect (blocked lumen) in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Convatec Inc. is recalling 4,760 units of SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Foley catheters. The recall was initiated after it was discovered that the lumen of the catheters was blocked by excess lubricious coating material.

The affected products are latex lubricous coated Foley catheters that incorporate one major drainage lumen and one or two minor lumens. The minor lumens are used for inflating the retention balloon and, in the case of 3-way catheters, for bladder irrigation. The blockage in the major drainage lumen compromises the device's intended function.

The recall number is Z-1241-2014, and the product code is 540204R001. The products were distributed worldwide and in the state of Texas. Consumers and healthcare providers should stop using the affected catheters and contact Convatec Inc. for further instructions or a replacement.

The recalled product

Product: SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc 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…
Manufacturer: Convatec Inc.
Category: Medical Device — Foley Catheters
Hazard: blocked-lumen
functional-defect
Affected units: 4,760

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.

See all 6 products in this recall →

Same manufacturer · Convatec Inc.

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Same hazard · blocked lumen