Medtronic, BD, Beckman Coulter, and Bausch + Lomb Initiate Multiple Voluntary Recalls of Medical Devices in China

Yiyao.com, June 25 — The National Medical Products Administration (NMPA) website issued an announcement stating that several globally renowned medical device companies have voluntarily recalled problematic products. The companies involved include Medtronic, Beckman Coulter, BD, and Bausch + Lomb....

 

 

On June 21, the National Medical Products Administration (NMPA) website announced that Beckman Coulter Commercial Trading (China) Co., Ltd. reported a voluntary Class I recall of the DxH600 Hematology Analyzer (Registration Certificate No.: Guo Xie Zhu Jin 20142405955) and the DxH800 Hematology Analyzer (Registration Certificate No.: Guo Xie Zhu Jin 20172401617) by the manufacturer, Beckman Coulter, Inc., due to the potential for sporadic erroneous elevation in platelet counts associated with these products.

 

 

According to observations by Saibailan Medical Devices, the company had already undergone two Class I recalls in 2019.

 

On February 11, Beckman Coulter Commercial Enterprise (China) Co., Ltd. reported a voluntary recall due to potential issues such as signal loss or signal drift with the product. The relevant product recall information was initially released on May 23, 2018, with a Class III recall level. The recall level has now been upgraded to Class I, and the number of units involved in the recall within China has been updated. The number of units involved in sales in China is 923.

 

 

On June 21, the National Medical Products Administration (NMPA) website announced that Beijing Bausch & Lomb Eye Care Products Co., Ltd. reported a voluntary recall of its soft hydrophilic contact lenses (Registration or Filing No.: Guo Xie Zhu Jin 20163220371) manufactured by Bausch & Lomb Incorporated. The recall was initiated due to clerical errors in the product’s Instructions for Use, where the correct refractive index value of “1.4036” was mistakenly printed as “1.4306” and included in the product packaging, among other reasons. The recall is classified as Level III.

 

 

 

Air Liquide Medical Supplies (Beijing) Co., Ltd. reported that, due toHospitalDuring the use of the MONNAL T75, when physicians employ ventilation modes capable of delivering pressure support—namely PSV, PSV-NIV, or PS-PRO—certain MONNAL T75 ventilators have exhibited the following behavior: if the pressure support is set to 2 cmH2O, users are unable to increase the PEEP setting, although they can decrease it to a lower level. If the user subsequently changes the ventilation mode, the aforementioned restriction persists. The inability to increase PEEP may lead to a risk of hypoventilation, which could adversely affect patients. This software malfunction is triggered only when the pressure support is changed to 2 cmH2O. Since the default setting for pressure support is 10 cmH2O, the frequency of this malfunction is limited. For these reasons, Air Liquide Medical Systems S.A. has initiated a voluntary recall of its ventilators (Registration or Filing Number: Guo Xie Zhu Jin 20153544098). The recall is classified as Class III.

 

 

 

On June 12, Medtronic (Shanghai) Management Co., Ltd. reported that the manufacturer, Medtronic Inc., had initiated a voluntary recall of the Sherpa NX Guiding Catheter (Registration Certificate No.: Guo Xie Zhu Jin 20163771283) due to the absence of distal outer material in the affected products. The recall is classified as Class II.

 

 

On June 21, the National Medical Products Administration (NMPA) website announced that Medtronic (Shanghai) Limited reported a voluntary recall by the manufacturer, Medtronic Inc., of the Mosaic Porcine Bioprosthesis (Registration Certificate No.: Guo Xie Zhu Jin 20173462038) and the Hancock II Porcine Bioprosthesis (Registration Certificate No.: Guo Xie Zhu Jin 20143136140) due to discrepancies between the packaging label dimensions and the actual product. The recall is classified as Class III.

 

 

 

On June 21, the National Medical Products Administration (NMPA) website announced that BD Medical Devices (Shanghai) Co., Ltd. reported a voluntary recall of three-way stopcocks for infusion use (Registration Certificate No.: Guo Xie Zhu Jin 20153660239) by the manufacturer Becton Dickinson Infusion Therapy AB, due to potential contamination of the sealed packaging of the affected products. The recall is classified as Class II.

 

 

 

As can be seen from the “Measures for the Administration of Medical Device Recalls” issued by the China Food and Drug Administration in 2017, medical device recalls are classified into three levels according to the severity of the defects.

 

The Measures stipulate that if a medical device manufacturer determines that its medical device products are defective, it shall immediately decide to initiate and implement a recall, while simultaneously releasing product recall information to the public. The use of such medical devices may have caused or has already caused seriousHealthClass I recalls are implemented for products that pose serious health hazards; Class II recalls are implemented for products that may cause or have caused temporary and reversible health hazards; Class III recalls are implemented for products where the likelihood of causing harm is low but a recall is still necessary.

 

For Class I recalls, the recall announcement shall be published on the website of the National Medical Products Administration and in major national media; for Class II and Class III recalls, the recall announcement shall be published in provincial-level foodDrugsPublished on the regulatory authority's website.

 

　　Medical DevicesProductionEnterpriseFollowing the decision to initiate a recall, Class I, Class II, and Class III recalls shall notify relevant medical device distributors, user facilities, or inform users within 1 day, 3 days, and 7 days, respectively.