China NMPA Product Recall - Ligation nail
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Teleflex Medical, Inc. has initiated a voluntary recall of its ligation staples following the identification of a critical manufacturing issue. The recall, reported by Teleflex Medical Devices Trading (Shanghai) Co., Ltd. and overseen by the National Medical Products Administration (NMPA), stems from a defect in the storage box that compromises a key function of the staple. This flaw may prevent the ligation staple from closing accurately or adequately on blood vessels, posing a risk of ineffective ligation. Furthermore, the tip of the staple could potentially cause damage to other distal anatomical structures during use. The affected products are registered under National Medical Device Registration Certificate No. 20153031694. While the specific recall level was not detailed in the provided information, the company has taken proactive steps to remove the product from circulation. Consumers and healthcare professionals are directed to consult the "Medical Device Recall Event Report Form" and the attached "Talifu Attachment.pdf" for comprehensive details regarding affected product models, specifications, and batch numbers. This action underscores the NMPA's commitment to ensuring the safety and efficacy of medical devices within its jurisdiction.
- Company
- Teleflex Medical
ID · 1c8ba227-b2bf-43ac-91a4-1f85c38ec498