Z-0496-2015Class II

Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) +M405P100C Intermediate...

Name: Z-0496-2015 Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate...
Creator: Cure Medical LLC
Published: 2014-11-11
License: https://open.fda.gov/license/

Cure Medical, LLC / initiated 2014-11-11 / Terminated / root cause: labeling and UDI

FDA source

Cure Medical LLC began a recall of Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC... on 2014-11-11. FDA classified it as Class II and gives the reason as "Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0496-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-11
Posted: 2014-12-16
Terminated: 2015-04-10
Recalling firm: Cure Medical, LLC
Product: Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage
Product code: EZD Catheter, Straight
Reason for recall: Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Cure Medical sent Urgent: Medical Device Correction and Removal Notification, dated November 11, 2014, to customers. The letter identified the affected product and the reason for the recall. Customers were asked to immediately quarantine all cases of P10 catheters, with Lot Number 140417-3, and destroy any boxes that are labeled as P8, Lot 140410-3 and contact us for replacement products. Additionally, if any cases of P10, Lot 140417-3 products or boxes of P8 products, Lot Number 140410-3 were further distributed, those customers were to be identified and notified of the problem via the enclosed letter, which includes instructions on what to do with any affected product. Cure Medical, LLC will work in cooperation with customers to cover expenses associated with this action. Customers were to complete and return the enclosed response form as soon as possible. If there are any questions, customers are to call Carole Harris at 949-723-0364, Monday-Friday, between 09:30 am and 05:00pm Pacific Time.
Quantity in commerce: 192 cases = 1,920 boxes = 57,600 each
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: 140417-3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0496-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0496-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-02

Product code EZD

K110653Class IICure CatheterCure Medical, LLC / cleared 2011-08-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)