FDA recommends against use of syringes, needles by Chinese firm after safety issues

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

(Reuters) – The U.S. Food and Drug Administration on Thursday asked healthcare providers to stop using certain syringes and needles with safety devices manufactured by Chinese medical device maker Guangdong Haiou Medical Apparatus Co (HAIOU).

At least one pharmacist that Reuters spoke to, said the syringes had been shipped for use with Pfizer Inc-BioNTech’s COVID-19 vaccine.

The U.S. health agency said it has received information about quality issues, including certain HAIOU needles detaching from the syringe and getting stuck to the patient’s arm after injection and a few incidents involving accidental needlestick injuries to healthcare providers.

The FDA has recommended against using two of HAIOU’s syringe-needle combinations – 1mL syringe with 25Gx 1-inch needle and the 1mL syringe with 23G x 1-inch needle – until further notice.

Erin Fox, senior director of drug information at University of Utah Health, said the university had previously received the syringes with the Pfizer Inc vaccine as part of ancillary supply kits shipped by McKesson Corp. She said they were using those syringes in March, but have not had them for a while and not currently using them.

The FDA issued an import alert on April 30, 2021 to prevent these syringe and needle configurations from entering the United States.

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