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
Recall
- Recall Number
- Z-0496-2015
- Event Number
- 69737
- Firm
- Cure Medical LLC
- FEI Number
- 3005471919
- Product Code
- EZD
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- November 11, 2014
- Posted
- December 16, 2014
- Terminated
- April 10, 2015
- Address
- 3700 Newport Blvd, Ste 301, Newport Beach, CA, 92663-3946
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
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.
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.
Nationwide Distribution
192 cases = 1,920 boxes = 57,600 each