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

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-shanghai-medical-devices-co-ltd/c2859847-70c7-4500-9701-5cdf819ff58b/
Source feed: China

> China NMPA product recall for Absorbable sutures (brand name: VICRYL Plus) by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. published March 18, 2019. Recall level: Level 2 Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling absorbable sutures (product name: VICRYL Plus) (see attached page).
- Company Name: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2019-03-18
- Product Name: Absorbable sutures (brand name: VICRYL Plus)
- Recall Level: Level 2 Recall
- Recall Reason: Issues may arise with absorbable stitching that is inconsistent with the sales unit cardboard box and aluminum foil label, particularly concerning specific product models and batches.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its absorbable sutures, specifically those marketed under the trade name VICRYL Plus. This regulatory action was officially reported on March 18, 2019, through notices issued by the Shanghai Food and Drug Administration and overseen by the National Medical Products Administration (NMPA). The primary issue identified was that certain models and batches of the VICRYL Plus sutures contained products that were inconsistent with their respective sales unit packaging and aluminum foil labels. This discrepancy raised concerns regarding accurate product identification and proper use. As a required action, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is undertaking this Class II recall to address the inconsistency and ensure the integrity and safety of its medical devices. The Class II designation indicates that the product's use may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse consequences is remote. Further detailed information regarding the affected models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-shanghai-medical-devices-co-ltd/c552b533-9bb4-43a8-858a-e58faf1dd14e/