USFDA flags made in China plastic syringes

USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety Communication on plastic syringes made in China earlier in November 2023. FDA’s concerns on Chinese made plastic syringes include performance & safety of the syringes, their ability to delivery correct dose of medication, problems of leaks, breakages; and the issues with quality of plastic syringes made in China and their distribution is more wide spread than originally known. FDA had issued Warning letter to a Chinese manufacturer Jiangsu Shenli Medical Production Co Ltd, is evaluating another Chinese manufacturer Jiangsu Caina Medical Co Ltd and also issued warning letters to US distributors Medline Industries, LP and Sol-Millennium Medical, Inc.

One of the major issues FDA has raised in the Warning letters is that the Firms market several models, sizes and colour variants of syringes without marketing clearances or approval and a Pre Market approval (PMA). FDA consider syringes as medical devices under section 201(h) of the Food, Drug, and Cosmetic Act as they used in diagnosis or cure of diseases and is regulated. Often the Firms have approval for one volume, size, model of a syringe but market several other sizes, models with different technological characteristics, colour variants without a 510(k) Pre Market Notification and this prevent FDA from evaluating these modifications. Addition of colour additives in syringes could result in adverse health effects including irritation, inflammation, pain, fever, organ stress, toxicity and organ failure. FDA is recommending suppliers, consumers and health care organisations to immediately transition from unauthorised plastic syringes from Chinese manufacturers. FDA contends that plastic syringes made in countries other than China including domestic manufacturing in US is adequate to support current healthcare demand.

FDA Update on Plastic Syringes Made in China (March 2024)