• Provision Consulting Group

FDA Warns Not Using Certain Needles With Safety Devices Made by HAIOU



The U.S. Food and Drug Administration on Thursday asked healthcare providers to stop using certain syringes and needles manufactured by Chinese medical device maker Guangdong Haiou Medical Apparatus Co (HAIOU). The agency has recommended against use of two of HAIOU's syringe-needle combinations below:


- 1mL syringe with 25G x 1-inch needle

- 1mL syringe with 23G x 1-inch needle


The FDA is aware of various Medical Device Reports (MDRs) as well as additional complaints where needles were reported to have detached from these HAIOU syringe and needle configurations and remained in the patient’s arm after injection, or the needle safety function failed (for example, did not activate or did not retract), and a small number of incidents involving accidental needlestick injuries to health care providers.


The FDA is not aware of any instances where surgery was needed to remove a needle. Risks associated with needles detaching in people’s arms and needle safety device failures could include pain, infection, and surgery (if the needle were to break in a person’s arm). There is also a risk to health care providers of transmission of bloodborne pathogens involving accidental needlestick injuries.


Despite pressure from the FDA, the manufacturer refuses to recall the affected syringes. As a result, the FDA issued an import alert on April 30, to prevent these syringe and needle configurations from entering the United States, and is currently working with federal partners to identify facilities where the needles were distributed to inform them of the quality issues.


Import Alert


The FDA is encouraging health care facility risk managers, procurement staff, and health care providers to stop using the syringes and needles, and to remove any remaining inventory from circulation. Facilities are also being encouraged to stop purchasing the HAIOU syringes until further notice.





Source: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-certain-syringes-and-needles-needle-safety-devices-manufactured-haiou-letter-health-care?utm_medium=email&utm_source=govdelivery

https://www.accessdata.fda.gov/cms_ia/importalert_244.html