NMPA Announces Medical Device Recalls Involving Abbott, Smith & Nephew, and Others

On May 6, the National Medical Products Administration announced a batch of medical device recall information.

 

 

Abbott Medical (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there were error messages displayed by the machine, causing the pressure-sensing function of the catheter to be disabled, and prompting physicians to replace the catheter product.

 

Manufacturer AbbottMedical DeviceAbbott Medical initiates a Level III recall of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (Registration No.: China Medical Device Registration No. 20203010469), a single-use magnetic and electrical positioning pressure monitoring ablation catheter.

 

 

Teleflex Medical Trading (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is a problem with the puncture needle hub cracking under pressure during catheterization. The manufacturer, Arrow International LLC, has initiated a voluntary recall of products such as percutaneous sheath puncture kits and central venous catheter kits. The recall level is Class III.

 

 

Agfa Healthcare Systems Equipment (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, where incorrect information was written on the RFID tags, the manufacturer Agfa NV has initiated a voluntary recall of Medical Dry Film (registration certificate codes: GJXZ 20200133, 20170743). The recall level is classified as Level Three.

 

 

Smith & Nephew Medical Products International Trade (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products with incorrect product label information, the manufacturer, U.S.-based Smith & Nephew, Inc., is voluntarily recalling the Total Knee System-Oxinium Femoral Implant and Journey II Knee System (registration certificate numbers: 20153132542, 20183130286). The recall level is classified as Level 2.

 

Smith & Nephew Medical Products International Trade (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products with manufacturing errors, the manufacturer, U.S.-based Smith & Nephew, Inc., is voluntarily recalling the TriGen InterTAN Hip Fracture Nailing System (registration certificate number: Guo Xie Zhu Jin 20143135639). The recall level is Class II.

 

 

bioMerieux Inc, the manufacturer of VITEK 2 System (Registration No.: GJXZ Jin 20152220990), has initiated a Level III recall due to issues with specific models and batches of products that may display incorrect test results on the LIS system. This was reported by Merieux Diagnostics Products (Shanghai) Co., Ltd.

 

 

Ruiyi Medical Devices (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, where the product inside the packaging was incorrect, the manufacturer, U.S.-based Ruiyi Medical Technology Co., Ltd., Wright Medical Technology, Inc., initiated a recall of the foot and ankle plate system ORTHOLOC 2.0/2.4 Forefoot Fracture System (registration certificate number: GJXZZJIN20143136161). The recall level is classified as Level III.