# China NMPA Product Recall - SwabCap Infusion Sterilization Connector

Source: https://www.globalkeysolutions.net/records/china_product_recall/icu-medical-inc/3d4b22b8-1eff-4a36-a3ff-bbd13ef898cf/
Source feed: China

> China NMPA product recall for SwabCap Infusion Sterilization Connector by ICU Medical Inc. published July 02, 2025. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) issued an announcement on July 2, 2025, detailin

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: ICU Medical Inc. of Aiyou Medical Products Co., Ltd. has initiated a voluntary recall of its infusion sterilization connectors.
- Company Name: ICU Medical Inc.
- Publication Date: 2025-07-02
- Product Name: SwabCap Infusion Sterilization Connector
- Recall Level: Level 2 Recall
- Recall Reason: Due to a manufacturing issue, the seal between the product's cotton swab cap foil cover and the plastic container may be incomplete, potentially causing isopropyl alcohol on the sponge to evaporate.
- Discovering Company: Smith Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: ICU Medical Inc.
- Summary: The National Medical Products Administration (NMPA) issued an announcement on July 2, 2025, detailing a voluntary recall initiated by ICU Medical Inc. of Aichio Medical Products Co., Ltd., also identified as Aiyou Medical Products Co., Ltd. The recall specifically concerns the company's Infusion Disinfection Connectors. This action is undertaken within the regulatory framework established by the NMPA, which oversees medical device safety and quality in China. The public notice, referenced under index number JGXX-2025-10084, confirms the company's proactive decision to remove these products from distribution. While the announcement specifies the product and the voluntary nature of the recall, it does not explicitly detail the main violations or specific issues prompting this action. The document indicates that a comprehensive 'Medical Device Recall Event Report Form' is attached, which would contain in-depth information regarding the root causes, the scope of the recall, and any further required actions or corrective measures implemented by the company. This process ensures adherence to regulatory standards aimed at safeguarding public health. Affected parties are directed to consult the official NMPA resources for the complete recall report and any subsequent updates.

Company: https://www.globalkeysolutions.net/companies/icu-medical-inc/d43e0557-60bd-4b28-91e2-1db6d11ab6dd/