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

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-optics-inc/0ea373d7-651e-4660-bce8-a125d06bba65/
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: . This National Medical Products Administration (NMPA) recall notice, published on May 17, 2017, detai

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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: This National Medical Products Administration (NMPA) recall notice, published on May 17, 2017, details a voluntary product recall initiated by Abbott Medical Optics Inc., the manufacturer of ophthalmic vitrectomy blades. The recall was reported on April 21, 2017, by Allergan (Shanghai) Medical Device Trading Co., Ltd., the product's distributor in China. The primary issue identified is a potential packaging error where 20GA and 25GA vitrectomy blades, used in conjunction with the AMO WHITESTAR SIGNATURE system for single-use vitrectomy surgery, may have been inadvertently mixed. This defect affects specific batches, including CA06180 for 20# blades and CA06182 for 25# blades. Under the regulatory oversight of the NMPA, Abbott Medical Optics Inc. is recalling the affected products. However, the recall specifies that these particular recalled batches were not sold or distributed within China. Consequently, no direct corrective actions are required for products within the Chinese market, as confirmed by Allergan (Shanghai) Medical Device Trading Co., Ltd. Despite this, the NMPA has requested provincial Food and Drug Administrations to enhance their supervision and management efforts, ensuring vigilance regarding medical device quality and safety.

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