# China NMPA Product Recall - Temperature probe / Reusable temperature probe / Temperature (TEMP accessory)

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-kincoway-shenzhen-industrial-co-ltd/5c1fb6ed-bf00-43a3-a5a9-7f5781e67642/
Source feed: China

> China NMPA product recall for Temperature probe / Reusable temperature probe / Temperature (TEMP accessory) by Philips Kincoway (Shenzhen) Industrial Co., Ltd. published March 30, 2022. Recall level: Level 3 Recall. Philips Kinco (Shenzhen) Industrial Co., Ltd. has initiated a voluntary Level III recall of specific

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Kinco (Shenzhen) Industrial Co., Ltd. is voluntarily recalling temperature probes/reusable temperature probes/temperature (TEMP accessories).
- Company Name: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Publication Date: 2022-03-30
- Product Name: Temperature probe / Reusable temperature probe / Temperature (TEMP accessory)
- Recall Level: Level 3 Recall
- Recall Reason: The instruction manual (IFU) for rectal/skin temperature probes contains insufficient information regarding the cleaning and disinfection process for reusable probes.
- Discovering Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Manufacturing Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Summary: Philips Kinco (Shenzhen) Industrial Co., Ltd. has initiated a voluntary Level III recall of specific temperature probes and reusable temperature accessories. This action, published by the National Medical Products Administration (NMPA) on March 30, 2022, addresses a significant concern identified through internal company monitoring. The primary issue involves inadequate cleaning and disinfection instructions within the instruction manuals (IFU) for their rectal and skin temperature probes. The affected products include temperature probes/reusable temperature probes/temperature (TEMP accessories) under model numbers 21075A, 21076A, and 21078A. The company is taking this proactive step to ensure patient safety and proper device use by rectifying the insufficient guidance on maintaining the sterility and cleanliness of these reusable medical devices. A Level III recall signifies that the product's use or exposure is not likely to cause adverse health consequences. This voluntary recall emphasizes the company's commitment to product quality and adherence to regulatory expectations for medical device labeling and user instructions.

Company: https://www.globalkeysolutions.net/companies/philips-kincoway-shenzhen-industrial-co-ltd/fe26b37f-e114-43d2-b1a3-85beed6a47a7/