FDA Warns Healthcare Providers Not To Use Certain Needles With Safety Devices Made By HAIOU

Federal health officials are urging medical providers to stop using certain syringes, which may be prone to detaching or breaking during use.

The U.S. Food and Drug Administration (FDA) issued the syringe warning on May 20, indicating multiple complaints have been received involving problems with syringes manufactured by Guangdong Haiou Medical Apparatus Co., LTD. (HAIOU).

The warning impacts HAIOU 1mL syringe with 25G x 1-inch needles and 1mL syringe with 23G x 1-inch needles, which consist of a needle attached to a hollow cylinder fitted with a sliding plunger. The needles are intended for standard injection or withdrawing of fluid from the body. These syringes and needle configurations may have been sold as individual units or as part of a kit.

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The FDA has received various Medical Device Reports (MDRs), as well as additional complaints, in which the needle safety function failed and the needles became detached and remained in the patient’s arm after injection. These include several reports of needle stick injuries to administrators.

A fractured needle could result in pain, infection, and surgery required to remove the remaining pieces, according to the FDA warning. Officials also warn needle stick injuries could lead to a transmission of bloodborne pathogens.

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.

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.

Customers are being asked to report any adverse events or suspected adverse events experienced with the products to the MedWatch Adverse Event Reporting program.


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