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

FDA device recall Z-0496-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Cure Medical LLC

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

EZD

Quantity affected

192 cases = 1,920 boxes = 57,600 each

Distribution

Nationwide Distribution

Date initiated

2014-11-11

Date posted

2014-12-16

Date terminated

2015-04-10

Location

Newport Beach, CA

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