Model/Item Numbers: 11101-000016 and 11101-000017Lot codes: 713609, 717912, 713904, 718033, 715008, 719323, 45932237, 46042286,45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054,46023823, 46078012 Manufacturing Dates: April 27, 2017 to August 10, 2017Distribution Dates: May 30, 2017 to September 4, 2017 Devices Recalled in theU.S.: 7,973 units nationwide. Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.
Posted 12/12/2017 FDA Link
