On May 20th, 2021, the FDA issued a warning recommending not to use certain syringes and needles with needle safety devices manufactured by Guangdong Haiou Medical Apparatus Co., LTD. (HAIOU). The FDA is asking health care facility risk managers, procurement staff, and health care providers to stop use of these items while they continue their evaluation. At this time, HAIOU has not initiated a recall on these select items, but the FDA did issue an import alert on April 30th, 2021 so faulty products do not enter the United States. The following devices in particular are being investigated:
- 1mL syringe with 25G x 1-inch needle
- 1mL syringe with 23G x 1-inch needle
Please read the full letter to health care providers below for more information. Stay well, mask up indoors, and stay tuned!