BEUDAMED
    FDA Enforcement Class II Terminated

    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation

    Recall: Z-1947-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1947-2013
    Event ID
    64971
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    April 22, 2013
    Classification Date
    August 13, 2013
    Termination Date
    June 16, 2015
    Address
    1500 S Waukegan Rd, Mpwm Bldg., Waukegan, IL, 60085-6728, United States

    Description

    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation

    Reason

    CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.

    Code Info

    1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668; 2) Product Code 2K8004; Lot Number: 0000355673; 3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677; 4) Product Code 2K8034; Lot Number: 0000355688; 5) Product Code 2K8035; Lot Number: 0000358023; 6) Product Code 2K8037; Lot Number: 0000358025; 7) Product Code 2K8040; Lot Number: 0000358026

    Distribution

    US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA

    Quantity

    14,112 units