China NMPA Product Recall - Absorbable sutures (brand name: VICRYL Rapide)

The National Medical Products Administration (NMPA) issued a recall report (Index No. JGXX-2010-10037) on May 19, 2010, for Absorbable Sutures (VICRYL Rapide) manufactured by Johnson & Johnson International and Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, formally reported on June 29, 2010, originated from an issue initially identified in 2008. The main problem was a packaging defect in certain suture batches produced between May and June 2007. This defect potentially compromised the integrity of the primary seal, which could lead to premature suture degradation and/or affect the product's sterility barrier. Due to complaints, an initially voluntary recall was extended to encompass all VICRYL RAPIDE* sutures manufactured during the May-June 2007 period. Affected models included 19962T, J9962T, VC532H, and VR917, impacting global markets, with significant numbers in China. As required actions, Johnson & Johnson contacted distributors and hospitals to facilitate the return of all recalled products, arranging for pickup and committing to provide replacements or compensation for all returned items.