The US Food and Drug Administration (FDA) is recommending healthcare facility risk managers, procurement staff, and healthcare 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
