China NMPA Product Recall - Skin adhesive (trade name: DERMABOND)

The National Medical Products Administration (NMPA) announced a voluntary global recall initiated by Ethicon LLC, a Johnson & Johnson subsidiary. Detailed in a report dated February 12, 2011, and published on February 22, 2011, the recall targets Ethicon's skin adhesive, DERMABOND (Registration Certificate Number: 2008 No. 3653022). The core issues leading to this recall were identified as discoloration and prolonged solidification time observed in specific product batches, including batch number CKE811. These quality deviations potentially compromise the product's intended efficacy and safe application. Under the regulatory guidance of the NMPA and various provincial food and drug administrations, Ethicon LLC, through its Chinese responsible unit, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., was mandated to implement immediate corrective measures. The required action involved the prompt recall of all affected DERMABOND products, specifically 12 BX units identified with these manufacturing defects, to safeguard patient safety and uphold medical device quality standards.