# China NMPA Product Recall - Liquid reservoir (trade name: CADD(R))

Source: https://www.globalkeysolutions.net/records/china_product_recall/smiths-medical-asd-inc/0760c506-a1f6-485d-a6bb-9349c94cfccf
Source feed: China

> China NMPA product recall for Liquid reservoir (trade name: CADD(R)) by Smiths Medical ASD, Inc. published November 28, 2017. Recall level: Level 1. On November 28, 2017, Smiths Medical ASD, Inc., in cooperation with its Chinese subsidiary Smith Med

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smiths Medical ASD, Inc. is voluntarily recalling its fluid reservoir (trade name: CADD(R)).
- Company Name: Smiths Medical ASD, Inc.
- Publication Date: 2017-11-28
- Product Name: Liquid reservoir (trade name: CADD(R))
- Recall Level: Level 1
- Recall Reason: Smith Medical discovered that the pressure plates used in the manufacturing process of some CADD reservoirs without flow protection may be faulty. Adhesion between the reservoir tubing and the infusion tubing could lead to partial or complete blockage of the infusion tubing, resulting in insufficient medication administration.
- Discovering Company: Smith Medical Devices (Beijing) Co., Ltd.
- Manufacturing Company: Smiths Medical ASD, Inc.
- Summary: On November 28, 2017, Smiths Medical ASD, Inc., in cooperation with its Chinese subsidiary Smith Medical Devices (Beijing) Co., Ltd., issued a voluntary Class I global recall for its CADD
R infusion cartridges, specifically Model 21-7002-24. This action was reported to and overseen by the National Medical Products Administration (NMPA). The primary issue identified was a manufacturing defect where an incorrect pressure plate was used in the production of these liquid reservoir devices. This critical flaw can result in the partial or complete blockage of the infusion tubing, which could lead to a severe consequence of insufficient medication administration to patients. While one serious injury globally has been attributed to this issue, no related patient harm reports have been received within China. A substantial volume of 331,890 affected units of this medical device were distributed and sold in China. To address the safety concern, required actions included issuing immediate emergency recall notices to all distributors. These notices mandated that distributors inform their customers and facilitate the prompt retrieval of all affected products. Subsequently, all recalled infusion cartridges are to be submitted to Stericycle for appropriate processing and disposal, ensuring removal from circulation and upholding patient safety standards.

Company: https://www.globalkeysolutions.net/companies/smiths-medical-asd-inc/d899a4ea-b7fd-4d01-8d91-a1b5b5df9993