After the FDA reported a potential quality issue related to China-made plastic syringes in November, BD increased its domestic manufacturing efforts.
In late 2023, the agency recommended healthcare workers stop using plastic syringes made in China-based facilities because of new dimensions, which customers said were linked to leaks and breaks. On March 19, the FDA confirmed the issue, alerting clinicians the problem is "more widespread than originally known."
The FDA issued warnings to two distributors and one manufacturer in China for allegedly selling unauthorized syringes.
The U.S. supply of plastic syringes is sufficient without these products, so a shortage is unlikely, the agency said. Nevertheless, BD began manufacturing more syringes at its Nebraska and Connecticut facilities, the company said in a March 21 news release.
BD said the FDA's notification does not include its syringes, but it has the capacity to meet higher demand for syringes.