# China NMPA Product Recall - Disposable sterile injection needle BD PrecisionGlide™ Needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/becton-dickinson-medical-s-pte-ltd/b157d903-810e-4d4c-be72-8db9ad28d594/
Source feed: China

> China NMPA product recall for Disposable sterile injection needle BD PrecisionGlide™ Needle by Becton Dickinson Medical (S) Pte. Ltd. published October 27, 2021. Recall level: Level 3. Becton Dickinson Medical(S) Pte. Ltd. initiated a voluntary Class III recall of its BD PrecisionGlid

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Becton Dickinson Medical (S) Pte. Ltd. is proactively recalling its single-use sterile BD PrecisionGlide™ Needle.
- Company Name: Becton Dickinson Medical (S) Pte. Ltd.
- Publication Date: 2021-10-27
- Product Name: Disposable sterile injection needle BD PrecisionGlide™ Needle
- Recall Level: Level 3
- Recall Reason: There are issues with inadequate packaging sealing or damaged packaging.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Becton Dickinson Medical (S) Pte. Ltd.
- Summary: Becton Dickinson Medical(S) Pte. Ltd. initiated a voluntary Class III recall of its BD PrecisionGlide™ Needle for Single-Use Sterile Injection Needles, as announced on October 27, 2021, by the National Medical Products Administration (NMPA). This action was prompted by identified issues concerning inadequate packaging sealing or damaged packaging within specific models and batches of the sterile injection needles. The recall was published by Becton Dickinson Medical (Shanghai) Co., Ltd., indicating a coordinated effort within the company's regional operations. The affected products, registered under Certificate No. 20193141616, are detailed in a separate Medical Device Recall Event Report Form. This recall highlights the importance of maintaining product sterility and integrity through robust packaging, which is crucial for patient safety in medical device usage. The Class III classification suggests that the probability of serious adverse health consequences from the use of, or exposure to, a violative product is remote. Becton Dickinson Medical(S) Pte. Ltd. is responsible for implementing the necessary steps to remove the affected batches from distribution and use, adhering to the NMPA's regulatory requirements for medical device safety and quality management. This proactive measure ensures compliance with health standards and safeguards public health.

Company: https://www.globalkeysolutions.net/companies/becton-dickinson-medical-s-pte-ltd/e493a0e7-56e4-4a78-9997-2ebd2adb9644/