FDA recommends against using syringes from Chinese company after vaccine injection safety concerns

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

The U.S. Food and Drug Administration on Thursday asked health care providers to stop using certain syringes and needles made by Chinese medical device maker Guangdong Haiou Medical Apparatus Co (HAIOU).

At least one pharmacist Reuters spoke to said the syringes were shipped for use with Pfizer Inc. / BioNTech SE COVID-19 vaccine.

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

The FDA said it received reports of quality issues, including the detachment of some HAIOU needles from the syringe and the patient’s arm being blocked after injection and a few incidents involving accidental needle stick injuries among providers. health care.

The agency recommended against using two of HAIOU’s syringe-needle combinations – a 1 ml syringe with a 25 G x 1 inch needle and the 1 ml syringe with a 23 G x 1 inch needle – until new order.

Erin Fox, senior director of drug information at the University of Utah Health, said she previously received the syringes containing the Pfizer / BioNTech vaccine as part of ancillary supply kits shipped by McKesson Corp (MCK.N). She said they were using these syringes in March, but haven’t had them for some time and are not currently using them.

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

Our standards: Thomson Reuters Trust Principles.


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