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FDA recommends not using syringes from Chinese firm after safety issues with vaccine injections

by Reuters
Thursday, 20 May 2021 21:22 GMT

(Adds FDA statement)

May 20 (Reuters) - The U.S. Food and Drug Administration on Thursday asked healthcare providers to stop using certain syringes and needles 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 the Pfizer Inc /BioNTech SE COVID-19 vaccine.

An FDA spokesperson said the devices stopped being shipped in COVID-19 vaccination kits as of March 22. The agency does not believe that stopping use of these syringes will cause vaccination delays.

The FDA 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 agency has recommended against use of 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 it had previously received the syringes with the Pfizer/BioNTech 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 are not currently using them.

The FDA issued an import alert on April 30, to prevent these syringe and needle configurations from entering the United States. (Reporting by Mrinalika Roy in Bengaluru and Michael Erman in New York; Editing by Shinjini Ganguli and Bill Berkrot)

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