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U.S. Department of Health and Human Services

Class 2 Device Recall The Cure Pediatric Catheter 10Fr

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  Class 2 Device Recall The Cure Pediatric Catheter 10Fr see related information
Date Initiated by Firm November 11, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on April 10, 2015
Recall Number Z-0496-2015
Recall Event ID 69737
510(K)Number K110653  
Product Classification Catheter, straight - Product Code EZD
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
Code Information Lot Number: 140417-3
Recalling Firm/
Manufacturer		 Cure Medical LLC
3700 Newport Blvd Ste 301
Newport Beach CA 92663-3946
For Additional Information Contact
800-570-1778
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EZD and Original Applicant = CURE MEDICAL LLC.
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