Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by HAIOU – Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers recommending that they stop using certain syringes and needles with needle safety devices manufactured by Guangdong Haiou Medical Apparatus Co., LTD. (HAIOU) until further notice. The FDA received information about quality issues, including certain HAIOU needles detaching from the syringe after injection and other needle safety device failures.

The Letter to Health Care Providers includes important information about certain syringe and needle configurations manufactured by HAIOU including:

• Details about the HAIOU syringe and needle configurations.
• Recommendations for health care facility risk managers, procurement staff, and health care providers.
• Actions the FDA has taken to address the quality issues.
• Instructions for reporting problems with the device to the FDA.

Questions?

If you have questions about syringes and needles with needle safety devices manufactured by HAIOU, contact the Division of Industry and Consumer Education (DICE)