Z-1240-2014Class II

'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL

Name: Z-1240-2014 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL
Creator: Convatec Inc.
Published: 2014-02-07
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2014-02-07 / Terminated / root cause: design

FDA source

Convatec Inc. began a recall of '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... on 2014-02-07. FDA classified it as Class II and gives the reason as "The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1240-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-03-20
Terminated: 2014-12-18
Recalling firm: ConvaTec Limited
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 constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
Product code: KOD Catheter, Urological
Reason for recall: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Root cause tag: design
FDA root cause: Device Design
Action: Convatec sent Urgent: Voluntary Medical Device Recall letters dated 2/7/2014 via UPS and email. Foreign customers were provided the notice via DHL. The letter identified the affected product, problem and actions to be taken. Customers are asked to perform a count of recalled product in inventory. All consignees should be contacted and be instructed to return product based on their procedures. Customers were instructed to complete and return the enclosed respoonse form.
Quantity in commerce: 54,590 catheters
Distribution: Worldwide Distribution and in the state of TX
Product codes and lots: 540204R001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1240-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1236-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-19
Z-1237-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-19
Z-1238-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-19
Z-1239-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-19
Z-1240-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-19
Z-1241-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-19

Product code KOD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)