China NMPA Product Recall - Automated suture cassette for laparoscopic surgery V-loc 180 Absorbable Reload / V-loc PBT Non-Absorbable Reload

Covidien LLC, a medical device manufacturer, through its subsidiary Covidien Medical Devices International Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of specific models and batches of its Automated Laparoscopic Suture Casing V-loc 180 Absorbable Reload and V-loc PBT Non-Absorbable Reload products. This recall, published by the National Medical Products Administration (NMPA) on January 31, 2023, stems from a critical issue involving needle breakage during use.

The affected products, identified by registration certificates 20153651978 and 20153021978, are subject to this action to address potential safety risks associated with the reported defect. While specific inspection dates were not provided in the public announcement, the recall underscores the regulatory oversight of the NMPA in ensuring medical device safety and quality within its jurisdiction.

As a required action, the company is facilitating the recall process, with comprehensive details regarding affected registration numbers, specifications, and batch numbers available in the "Medical Device Recall Event Report Form" attached to the NMPA's official notice. This voluntary recall is a proactive measure to mitigate risks to patients and healthcare professionals.