Three Large Foreign-funded Enterprises Recall Equipment!

On March 18, NMPA issued a notice on the recall of three batches of products.

There are two three-level recalls and one two-level recall. The products involved are: nucleic acid extraction reagent of BD Pharmingen TM patient monitor of Edwards lifesciences (Shanghai) and soft hydrophilic contact lens of Cooper Vision.

Details of the recall notice are as follows:

1. CooperVision Inc. actively recalled the soft contact lens of soft hydrophilic contact lens

 CooperVision  (Shanghai)Trading Co., Ltd. reported that due to the inclusion of foreign matters in the blister packaging of products involving specific models and batches of products, the manufacturer CooperVision Inc. actively recalled the soft contact lens (Registration Certificate No.: GXZJ 20153162423).

The recall level is level 3

2.BD PharmingenTM voluntarily recalls nucleic acid extraction reagent BD MAXTM ExKTM TNA-3

 BD PharmingenTM reported that Becton, Dickinson and Company actively recalled the nucleic acid extraction reagent BD Maxtm Exktm tna-3 (filing certificate code: GXB No. 20170403) due to the exposure to the temperature exceeding the claimed stability of the product due to specific models and batches of products.

The recall level is level 3

3.Edwards Lifesciences LLC voluntary recall of patient monitor hemodynamic modularized multi-parameter monitoring platform

Edwards (Shanghai) Medical Products Co., Ltd. reported that due to the low value of tissue oxygen saturation St02 in specific models and specific batches of products, the manufacturer Edwards Lifesciences LLC (Registration Certificate Number: GXZJ 20183210254) voluntarily recalled.

The recall level is level 2.

BradyKnows has seasoned staff in registration and can help manufacturers on legal compliance. If you have any questions, please feel free to contact us  info@bradyknowsmedical.com for more information.