# China NMPA Product Recall - 20# glass cutter, 25# glass cutter

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-optics-inc/ccc13265-94ea-478e-b8e1-71755d31f06c/
Source feed: China

> China NMPA product recall for 20# glass cutter, 25# glass cutter by Abbott Medical Optics Inc. published May 17, 2017. Recall level: . The National Medical Products Administration (NMPA) issued a recall notice on May 17, 2017, regardin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical Optics Inc. recalls vitrectomy blades.
- Company Name: Abbott Medical Optics Inc.
- Publication Date: 2017-05-17
- Product Name: 20# glass cutter, 25# glass cutter
- Recall Reason: This recall is being initiated due to a possible packaging error, specifically that products in the packaging of a 20GA glass cutter and a 25GA glass cutter may have been mixed up.
- Discovering Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Manufacturing Company: Abbott Medical Optics Inc.
- Summary: The National Medical Products Administration (NMPA) issued a recall notice on May 17, 2017, regarding vitrectomy blades manufactured by Abbott Medical Optics Inc. and distributed by Allergan (Shanghai) Medical Device Trading Co., Ltd. This voluntary recall, reported on April 21, 2017, was initiated due to a potential packaging error where 20GA and 25GA glass cutters for ophthalmic phacoemulsification devices (Registration Certificate No.: CFDA (Imported) 2013 No. 3234023) might have been inadvertently mixed. These single-use blades are essential for vitrectomy surgeries and are designed for use with the AMO WHITESTAR SIGNATURE system.

While the manufacturer undertook a global recall for affected batches (e.g., CA06180, CA06182), Abbott Medical Optics Inc. confirmed that the recalled products were not sold or imported into the Chinese market. Consequently, no specific corrective actions were mandated for users or distributors within China. However, the NMPA requested all provincial Food and Drug Administrations to enhance their supervision and management efforts to ensure compliance. This proactive measure by the manufacturer, under the NMPA's oversight, addressed the potential product mix-up, upholding patient safety standards even though the direct impact on the Chinese market was averted.

Company: https://www.globalkeysolutions.net/companies/abbott-medical-optics-inc/880596cf-ac9e-4b01-bce5-e1a8dab0e081/