China NMPA Product Recall - ArcticGel Pads

Medivance Inc., the manufacturer, has initiated a voluntary recall of its ArcticGel Pads, as reported by Bard Medical Technology (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA) on March 10, 2016, with publication on April 13, 2016. The primary issue identified is excessively low flow rates within the energy transfer mats. A thorough investigation revealed that the defect stemmed from the manufacturing process, specifically over-lamination during production. This caused the film to be over-compressed on the foam pads and subsequently crushed the pad posts, restricting water flow through the channels. Although the recall affects various models and all lots within their expiration date across 64 countries including Germany, Japan, and the U.S., Medivance Inc. confirmed that no recalled products were distributed or sold in the Chinese market. The identified risk to end-users is considered marginal, potentially leading to a slight delay in therapy delivery without associated long-term clinical consequences, provided timely alternative treatment is administered. In response, Medivance Inc. has implemented a Corrective and Preventive Action (CAPA) to rectify the lamination process. All affected manufacturing equipment was taken out of service on September 11, 2015. Furthermore, recall letters are being issued to consignees to facilitate information collection and replacement of unused affected products. The NMPA has also requested provincial, autonomous region, and municipal food and drug administrations to enhance supervision and management of such medical devices.