# China NMPA Product Recall - Disposable sterile syringe with needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/changchun-jinkangyuan-medical-equipment-co-ltd/205374e1-eba4-4394-b9cf-eeb14d92241a/
Source feed: China

> China NMPA product recall for Disposable sterile syringe with needle by Changchun Jinkangyuan Medical Equipment Co., Ltd. published November 15, 2017. Recall level: Level 3. Changchun Jinkangyuan Medical Device Co., Ltd. initiated a Level III voluntary recall for a specific

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Changchun Jinkangyuan Medical Instrument Co., Ltd. is recalling disposable sterile syringes (with needles).
- Company Name: Changchun Jinkangyuan Medical Equipment Co., Ltd.
- Publication Date: 2017-11-15
- Product Name: Disposable sterile syringe with needle
- Recall Level: Level 3
- Recall Reason: Suspected product quality issues
- Discovering Company: Changchun Jinkangyuan Medical Equipment Co., Ltd.
- Manufacturing Company: Changchun Jinkangyuan Medical Equipment Co., Ltd.
- Summary: Changchun Jinkangyuan Medical Device Co., Ltd. initiated a Level III voluntary recall for a specific batch of its Disposable Sterile Syringes (with Needles), model 5ml 0.6, batch number 20170208, under CFDA Registration No. 20143150630. This action was prompted by a quality supervision and sampling inspection conducted by the Jilin Provincial Drug Inspection Team on April 11, 2017, which revealed that the products did not meet established standard requirements. The recall aimed to ensure consumer safety and adherence to product efficacy standards.Operating under the National Medical Products Administration's (NMPA) "Regulations on the Management of Medical Device Recalls," the company implemented swift corrective measures. Notifications to responsible consignees commenced on April 11, 2017, with subsequent outreach to other consignees on April 13, 2017. The recall successfully collected all 34,200 affected units, which were then secured and sealed in the company's warehouse pending further test results. The entire recall process was reportedly completed within one week. The NMPA publicly announced this recall on November 15, 2017, emphasizing its commitment to medical device quality oversight.

Company: https://www.globalkeysolutions.net/companies/changchun-jinkangyuan-medical-equipment-co-ltd/92ebf19f-7a8d-4225-bc2a-d521497eb3e1/