May 20, 2021
The U.S. Food and Drug Administration (FDA) is recommending health care facility risk managers, procurement staff, and health care providers stop using certain syringes and needles with needle safety devices manufactured by Guangdong Haiou Medical Apparatus Co., LTD. (HAIOU) at this time while FDA continues our evaluation.
The FDA received information about quality issues, including certain HAIOU needles detaching from the syringe after injection and other needle safety device failures. These device failures have been reported for the following HAIOU syringe and needle configurations (combinations of syringes and needles with needle safety devices):
- 1mL syringe with 25G x 1-inch needle
- 1mL syringe with 23G x 1-inch needle
The FDA recommends health care facility risk managers, procurement staff, and health care providers:
- Stop using and remove from your inventory the 1mL syringe with 25Gx 1-inch needle and the 1mL syringe with 23G x 1-inch needle configurations (combinations of syringes and needles with needle safety devices) manufactured by HAIOU until further notice. Users and facilities that decide to dispose of applicable unused product should follow facility processes for sharps disposal.
- Do not purchase these HAIOU syringes and needle configurations until further notice.
- Be aware that these syringes and needle configurations may be available as individual units or may be included as part of a kit.
- Currently, we are not aware of concerns with other products (such as gloves, alcohol pads, etc.) that may be provided in kits alongside the 1mL syringe with 25Gx 1-inch needle and the 1mL syringe with 23G x 1-inch needle configurations, but these HAIOU syringes and needle configurations should not be used.
- Report any issues with the quality or performance of these devices to the FDA. See Reporting Problems to the FDA below.
Generally, a syringe is used to inject fluid into, or withdraw fluid from, the body. The HAIOU syringe and needle with needle safety device configurations consists of a needle attached to a hollow cylinder that is fitted with a sliding plunger. The needle safety feature should retract the needle into the syringe after an injection through manual withdrawal of the plunger to minimize the risk of accidental needlestick injuries.
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.
To date, HAIOU has declined to initiate a voluntary recall. The FDA issued an import alert on April 30, 2021 to prevent these syringe and needle configurations from entering the United States. The FDA is working with federal partners to identify where these configurations have been distributed and inform those sites of the quality issues.
The FDA is evaluating whether other HAIOU syringe and needle configurations may have similar problems, and will continue to keep facilities, health care providers and the public informed if significant new information becomes available.
Reporting Problems to the FDA
The FDA encourages health care facility risk managers, procurement staff, and health care providers to report any adverse events or suspected adverse events experienced with any syringe and needle configurations.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).