# China NMPA Product Recall - Breathing circuit

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-iic/f80ce30e-2e1e-424e-880c-c56795ad9de9/
Source feed: China

> China NMPA product recall for Breathing circuit by Covidien IIc published December 07, 2016. Recall level: Level III. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Level III 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical International Trading (Shanghai) Co., Ltd. initiates voluntary recall of breathing circuits.
- Company Name: Covidien IIc
- Publication Date: 2016-12-07
- Product Name: Breathing circuit
- Recall Level: Level III
- Recall Reason: Medtronic is conducting this voluntary recall due to material differences discovered between the Covidien breathing circuit products actually imported into China and the registered products at the time of importation. The registered product (model 300/6042) contains DEHP plasticizer in its interface, while the affected products imported into China do not. The registered product (model 306/6948) uses Styrolux for its water collection cup, while the affected products imported into China use polypropylene. Our investigation has determined that these differences do not affect the performance and safety of the Covidien breathing circuit.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien IIc
- Summary: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall of specific breathing circuit models (15K1561FAX and 15J0992FAX) in China, with the recall reported on December 7, 2016. The primary issue stemmed from a discrepancy where the materials used in the imported breathing circuits differed from those officially registered with the National Medical Products Administration (NMPA).

For instance, the registered interface for model 300/6042 included DEHP plasticizer, which was absent in the imported versions. Similarly, for model 306/6948, the registered product specified Styrolux for its water collection cup, while the imported products utilized polypropylene. While Covidien stated these material variations did not compromise product performance or safety, they represented a non-compliance with the established regulatory requirements for registered product specifications.

Under the NMPA regulatory framework, Covidien, acting through Medtronic, directed all affected customers via email to verify their inventory for the identified batch numbers. Customers are required to return any affected products to Medtronic for centralized destruction, ensuring adherence to regulatory standards and preventing further distribution of non-conforming items.

Company: https://www.globalkeysolutions.net/companies/covidien-iic/6e4e759f-1687-4f35-b665-0b4282e7e89e/