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Class 2 Device Recall The Cure Pediatric Catheter 10Fr |
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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
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Product Classification |
Catheter, straight - Product Code EZD
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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
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Code Information |
Lot Number: 140417-3 |
Recalling Firm/ Manufacturer |
Cure Medical LLC 3700 Newport Blvd Ste 301 Newport Beach CA 92663-3946
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For Additional Information Contact |
800-570-1778
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = EZD and Original Applicant = CURE MEDICAL LLC.
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