Counterfeit "INLINE-SITE Needle Free Connector" New
The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Needleless Airtight Infusion Connector Protector" from the manufacturer "Zhejiang Runqiang Medical Instruments Co., Ltd.".
It cannot be ruled out that this counterfeit is also on the Austrian market. Counterfeit medical devices are technically unsafe or have no or an unpredictable effect or function and are therefore to be classified as dangerous. They must not be used under any circumstances.
The counterfeit is an imitation of the legitimate product "Needleless Airtight Infusion Connector Protector". This is a product for ensuring long-term intravenous access for the administration of medication, fluids, total parenteral nutrition (TPN), chemotherapy and blood sampling.
According to the manufacturer of the legitimate product, the counterfeits can be recognised by the following feature:
- According to its labelling, the counterfeit product is distributed by the Italian company HEKA S.r.l.. The logo, address and address of the dealer can be seen on the product label. The reference number REF: EBNF001 and the LOT no.: 624424 are stated on the product label. In addition, the counterfeit can be recognised by the fact that there is no UDI on the product label.
There is a potential health risk, as the function, safety and efficacy of counterfeit medical devices are not given or cannot be assessed. Counterfeit medical devices are not manufactured in accordance with the quality standards and legal requirements applicable to legitimate original products. They have an unknown origin.
The counterfeit in question poses the following known risk: problems with leakage when administering fluids or medication via the needle-free connector (hub) and lack of flow of fluids or medication during the application of infusions.
Zhejiang Runqiang Medical Instruments Co., Ltd. is not the manufacturer of the counterfeit product and therefore not responsible for it.
The BASG asks you to report any suspicious observations in connection with the above-mentioned products by e-mail to the BASG(medizinprodukte@basg.gv.at) and the authorised representative of the manufacturer (Shanghai International Holding Corp. GmbH (Europe), shholding@hotmail.com or the contact person Tian Xiaoyong, saraht@shholdingeu.com).
| Medical devices | Not to be confused with INLINE-SITE Needle Free Connector |
|---|---|
| Manufacturer | Unknown |
| Batch number(s) | 624424 |
| Further information Link | /fileadmin/redakteure/03_amtlicheNachrichten/Medizinprodukte/GZ_3837176_Abbildung_Fälschung.pdf |
