China NMPA Product Recall - Glass cutter (No. 20 glass cutter, No. 25 glass cutter)
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The National Medical Products Administration (NMPA) published a recall notice concerning Vitrectomy Blades manufactured by Abbott Medical Optics Inc. The recall, reported by the Chinese distributor Allergan (Shanghai) Medical Device Trading Co., Ltd. on April 21, 2017, pertains to a potential packaging error where 20GA and 25GA vitrectomy blades might have been mixed. These single-use surgical tools, registered under CFDA (Imported) 2013 No. 3234023, are integral for ophthalmic procedures to remove vitreous humor. Abbott Medical Optics Inc. initiated this voluntary recall. Crucially, the manufacturer confirmed that the affected product batches (e.g., CA06180, CA06182) were never sold or distributed within China, negating the need for local corrective actions. Despite no direct impact on the Chinese market, the NMPA instructed provincial Food and Drug Administrations to reinforce their oversight and management of medical devices, underscoring regulatory vigilance.
- Company
- Abbott Medical Optics Inc.
ID · c9918c5f-88bb-47a0-8249-9141ce045109