Tuesday, 23 April, 2024
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FDA issues warning on Chinese syringe products

A warning from the US Food & Drug Administration last week regarding Chinese-made plastic syringes has alarmed healthcare workers and others.

The FDA said several Chinese manufacturers had changed syringe dimensions, causing leaks and breakages, reports Becker’s Hospital Review.

The agency said it was working with federal partners and manufacturers, and that it “may prevent syringes made in China from entering the United States”.

In the two weeks before the FDA’s warning, US medical device-makers had issued warnings about their syringe infusion pumps having compatibility issues with modified syringes. A total of 32m Cardinal Health syringes have different dimensions from older brands, and B Braun Medical is reporting a similar issue for 33.8m syringe pump sets.

“The tubing outer diameter may vary in size or the length of tubing may be too short,” B Braun said in an FDA post, which classifies the issue as a Class I recall.

“Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients that could be life-threatening or lead to death.”

Baxter International is also warning customers of incomplete infusions because of syringe sizes and occlusion alarms. The company sent an Urgent Medical Device Correction for its Novum IQ syringe infusion pump because it might display “infusion complete” while fluid remains in the syringe.

The FDA is recommending that healthcare workers prioritise syringes manufactured in other countries.

Glass syringes, pre-filled syringes, and syringes used for oral or topical purposes are not part of the quality control concern, the FDA said.

 

Becker’s Hospital Review article – Millions of syringe products in chaos as FDA probes China-made devices (Open access)

 

See more from MedicalBrief archives:

 

Anger in China over faulty vaccine scandal

 

Sloppy standards at Chinese labs pose risk of deadly pathogen leaks

 

Chinese drug regulator officials sacked over rabies vaccine scandal

 

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