# China NMPA Product Recall - Disposable puncture care kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/haolang-technology-foshan-co-ltd/ac5202ba-a885-416d-9e73-1488522f8f2a/
Source feed: China

> China NMPA product recall for Disposable puncture care kit by Haolang Technology (Foshan) Co., Ltd. published August 15, 2019. Recall level: Level 3 Recall. Haolang Technology (Foshan) Co., Ltd. initiated a voluntary Class III recall of its Disposable Punct

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Haolang Technology (Foshan) Co., Ltd. has initiated a voluntary recall of its disposable puncture care kits.
- Company Name: Haolang Technology (Foshan) Co., Ltd.
- Publication Date: 2019-08-15
- Product Name: Disposable puncture care kit
- Recall Level: Level 3 Recall
- Recall Reason: Haolang Technology Foshan Co., Ltd. discovered that the components of the nursing kit produced in April 2019, batch number 1904018, were inconsistent with the configuration under the registered specification CH-09. The actual product configuration did not include a scalpel, butterfly clamp, and forceps.
- Discovering Company: Haolang Technology (Foshan) Co., Ltd.
- Manufacturing Company: Haolang Technology (Foshan) Co., Ltd.
- Summary: Haolang Technology (Foshan) Co., Ltd. initiated a voluntary Class III recall of its Disposable Puncture Care Kits in August 2019, under the regulatory oversight of China's National Medical Products Administration (NMPA). The recall primarily affects product batch number 1904018, manufactured in April 2019. The main issue identified was an inconsistency between the actual product configuration and its registered specifications (model CH-09). Specifically, essential components such as a scalpel, butterfly clamp, and forceps were missing from the kits. While the company noted that these kits are often used with CVC catheter kits that already contain these instruments and no adverse events have been reported, the deviation from registered design necessitates corrective action. As required actions, Haolang Technology instructed distributors to issue recall notices to their customers and retrieve all affected products. These returned kits are to be sent back to Haolang Technology (Foshan) Co., Ltd. for proper disposal, ensuring compliance with medical device standards.

Company: https://www.globalkeysolutions.net/companies/haolang-technology-foshan-co-ltd/179a547d-193e-4ae1-a297-e819f36488bc/