# China NMPA Product Recall - Disposable percutaneous drainage cannula

Source: https://www.globalkeysolutions.net/records/china_product_recall/baguang-trading-shanghai-co-ltd/fed28180-b9d0-47db-80c7-1c2d31075eae/
Source feed: China

> China NMPA product recall for Disposable percutaneous drainage cannula by Baguang Trading (Shanghai) Co., Ltd. published June 29, 2020. Recall level: Level 3 Recall. Baguang Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its disposable percu

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baguang Trading (Shanghai) Co., Ltd. has voluntarily recalled disposable percutaneous puncture drainage cannulas.
- Company Name: Baguang Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-06-29
- Product Name: Disposable percutaneous drainage cannula
- Recall Level: Level 3 Recall
- Recall Reason: The issue concerns a discrepancy between the Chinese instruction manual and the product registration certificate for a disposable percutaneous puncture drainage cannula (PTCD) (J-type guide wire) with a specification of 0.8*800mm. 1. The instruction manual states that the product can be left in the body for >24 hours to 30 days, classifying it as long-term indwelling. However, the corresponding 2015 product registration certificate (National Medical Device Registration Certificate 20153151697) only lists the indwelling time as >24 hours to 30 days, without mentioning "long-term indwelling." 2. The instruction manual uses a 0.8*800mm guide wire for the one-step PTCD procedure, while the 2015 product registration certificate (National Medical Device Registration Certificate 20153151697) specifies a 0.9×800mm guide wire. The 0.8*800mm guide wire is for the two-step PTCD procedure.
- Discovering Company: Baguang Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baguang Trading (Shanghai) Co., Ltd.
- Summary: Baguang Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its disposable percutaneous drainage cannulas (PTCD) on June 29, 2020. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, stemmed from identified inconsistencies between the product's Chinese instructions for use and its NMPA registration certificate (National Medical Device Registration No. 20153151697).

The main issues involved two critical discrepancies. Firstly, the instructions for use indicated an indwelling time of "> 24h~30 days" and characterized it as "long-term indwelling." In contrast, the 2015 product registration certificate only specified ">24h~30 days" without the 

Company: https://www.globalkeysolutions.net/companies/baguang-trading-shanghai-co-ltd/16b96352-6b75-4d1f-a383-34c535a9ceab/