Pediatric, 10Fr, Intermittent Urinary Catheters recallZ-0496-2015 · Cure Medical LLC · initiated Nov 11, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cure Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0496-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 11, 2014
- Posted by the FDA
- Dec 16, 2014
- Recalling firm
- Cure Medical LLC
- Quantity
- 192 cases = 1,920 boxes = 57,600 each
- Product code
- EZD
- FDA submissions
- K110653
- Distribution
- Nationwide Distribution
Product description
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
Code information (models, lots, serial numbers)
Lot Number: 140417-3
Other devices under the same FDA submission
1 device cleared under K110653 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CURE CATHETER P14Convatec, Purchasing Department · Catheter, Straight1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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