# China NMPA Product Recall - Disposable tubing kit (ophthalmic phacoemulsification therapy device)

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-vision-care-inc/27bc6ca6-86cd-454e-a392-dd10fe8ecf1e
Source feed: China

> China NMPA product recall for Disposable tubing kit (ophthalmic phacoemulsification therapy device) by Johnson & Johnson Vision Care Inc. published February 21, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) published a Class II voluntary recall notice on 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson Surgical Vision, Inc. is voluntarily recalling single-use tubing kits.
- Company Name: Johnson & Johnson Vision Care Inc.
- Publication Date: 2023-02-21
- Product Name: Disposable tubing kit (ophthalmic phacoemulsification therapy device)
- Recall Level: Level 2 Recall
- Recall Reason: There are prominent issues with non-compliant welds.
- Discovering Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Manufacturing Company: Johnson & Johnson Vision Care Inc.
- Summary: The National Medical Products Administration (NMPA) published a Class II voluntary recall notice on February 21, 2023, concerning specific models and batches of single-use tubing kits manufactured by Johnson & Johnson Surgical Vision, Inc. These devices are used for ophthalmic phacoemulsification therapy. The recall was initiated due to a manufacturing defect identified as a non-compliant weld protrusion issue within the products. Allergy Care (Shanghai) Medical Device Trading Co., Ltd. reported this issue, prompting the manufacturer's proactive measure. The Class II designation from the NMPA signifies that the defect could potentially lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. The required action for affected parties includes the immediate cessation of use and the return of the recalled tubing kits. Comprehensive details regarding the specific models, specifications, and batch numbers impacted by this recall are outlined in the accompanying 'Medical Device Recall Event Report Form' referenced in the NMPA's official communication.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-vision-care-inc/97a98f3f-3fbb-40b6-8ba1-5a6e8537a514