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

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-international-co-european-logistics-center/84c91736-d3a8-4011-844c-d708261cd35c/
Source feed: China

> China NMPA product recall for Absorbable sutures (brand name: VICRYL Rapide) by Johnson & Johnson International, c/o European Logistics Center published May 19, 2010. Recall level: . The National Medical Products Administration (NMPA) issued a recall report (Index No. JGXX-2010-1003

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Report Form for Absorbable Sutures (Brand Name: VICRYL Rapide)
- Company Name: Johnson & Johnson International, c/o European Logistics Center
- Publication Date: 2010-05-19
- Product Name: Absorbable sutures (brand name: VICRYL Rapide)
- Recall Reason: The manufacturer initiated a recall in 2008 after discovering a packaging defect in certain batches of sutures produced between May and June 2007. This packaging defect could affect the integrity of the primary seal, potentially leading to premature degradation of the sutures and/or compromising the product's sterility barrier. Based on complaint reports, the manufacturer decided to extend the aforementioned voluntary recall to include all other batches of VICRYL RAPIDE* sutures produced between May and June 2007.
- Discovering Company: Johnson & Johnson International c/o European Logistics Center
- Manufacturing Company: Johnson & Johnson International, c/o European Logistics Center
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-international-co-european-logistics-center/1ef45e4b-d2cd-4f02-a6cc-6272d0f5325b/