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FDA recommends not using certain syringes from Chinese firm after safety issues

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(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. ...

 

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