China NMPA Product Recall - Glass cutter
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On June 12, 2017, the National Medical Products Administration (NMPA) announced a voluntary recall initiated by Abbott Medical Optics Inc., with distribution handled by Allergan (Shanghai) Medical Device Trading Co., Ltd. The recall pertains to an ophthalmic phacoemulsification device, specifically due to identified packaging errors within its blade components. While several model numbers, including 166570 and 166571, were affected, Abbott Medical Optics Inc. confirmed that these recalled products were not sold in China.
Under the NMPA's regulatory guidance, food and drug administrations across autonomous regions and municipalities directly under the central government were instructed to strengthen their supervision and management of similar medical devices. This proactive recall by the manufacturer underscores the industry's commitment to maintaining high standards of product quality and safety, addressing potential issues such as packaging integrity before products reach the market. The incident highlights the ongoing importance of robust quality control and regulatory oversight in the medical device sector.
- Company
- Abbott Medical Optics Inc.
ID · 48cc2436-e333-4846-9d29-dd73b78fc09f