Agency classClass IIOur severity:High FDA (Devices)·Z-1239-2014·Announced 2014-03-26

Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

Convatec Inc. is recalling 31,250 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. A blocked lumen in a medical device presents a risk of harm (such as urinary retention or infection) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Convatec Inc. is recalling 31,250 units of JMS, Japan, 3 Way, 20 FR 10 mL Latex Lubricous 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 products were distributed worldwide and in the state of Texas. The product code associated with this recall is 540204R001.

Consumers who have these specific catheters should stop using them and contact Convatec Inc. for further instructions or a replacement.

The recalled product

Product: JMS, Japan, 3 WAY, 20 FR 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 lumens constructed in the wall of the…
Manufacturer: Convatec Inc.
Category: Medical Device — Catheters
Hazard: blocked-lumen
excess-coating
Affected units: 31,250

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