The Medicines and Healthcare Products Regulatory Agency (MHRA) of United Kingdom posted a medical device safety alert concerning ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect manufactured by Physio-Control Inc. [Catalogue number: 11996-000017; MIN number: 3202674-005; Lot numbers: 516907, 519815, 519816].
The manufacturer conducted a voluntary recall of the abovementioned product due to a low-level potential for damage to the wire insulation during the manufacturing process of these specific lots. The defibrillation electrodes used in conjunction with certain Physio-Control LIFEPAKR products. The use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician bum.
The manufacturer advises customers to quarantine the affected products and return them to the manufacturer.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 February 2016