BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-0496-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0496-2015
    Event ID
    69737
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cure Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    November 11, 2014
    Classification Date
    December 2, 2014
    Termination Date
    April 10, 2015
    Address
    3700 Newport Blvd Ste 301, N/A, Newport Beach, CA, 92663-3946, United States

    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

    Reason

    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.

    Code Info

    Lot Number: 140417-3

    Distribution

    Nationwide Distribution

    Quantity

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