China NMPA Product Recall - Absorbent alginate dressing (brand name: Meijishuang)

Molnlycke Medical Supplies (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific batches of its Absorbable Alginate Dressings (Trade Name: Meijishuang/Melgisorb Absorbent Calcium Sodium Alginate Dressing, Part Number: 251100, Lot Number: 13383242). The company discovered that these products were manufactured with a production date falling outside the validity period of their official registration certificate. This non-compliance violates Chinese regulatory requirements for medical devices, specifically those overseen by the National Medical Products Administration (NMPA). The recall, affecting 50 boxes sold in China out of 380 imported, was self-reported by the company on April 10, 2015.

Despite the regulatory discrepancy, Molnlycke Medical Supplies confirmed that no adverse patient reactions or product defects have been reported, and the use of these products is not expected to cause any adverse health effects. The recall is primarily a measure to ensure full compliance with regulatory standards and to maintain responsibility towards patients and society. Required actions include filing a report with the NMPA, notifying all affected distributors, confirming the quantities of unused products, and arranging for distributors to return the affected batches. These products will then be isolated for further instructions regarding return or disposal. This recall is limited to the specified batch.