Syringes Cited for Violations

The U.S. Food and Drug Administration (FDA) Center put out a warning to the medical industry to stop using plastic syringes made in China. The syringes are distributed in the U.S. and have widespread quality control issues. The plastic syringes may break or deliver incorrect doses, which can cause life-threatening medication errors.

Facility inspection and syringe testing were conducted on March 18 by the FDA at Jiangsu Shenli Medical Production Company LTD products, based in China. The inspection and syringe testing were also conducted at distributors Medline Industries LP and Sol-Millennium Medical Inc., both based in Illinois.

The ongoing evaluation confirmed that issues with the quality of plastic syringes made in China and their distribution in the U.S. are more widespread than originally known. The FDA had sent warning letters to three Chinese manufacturers citing violations related to the sale and distribution of unauthorized plastic syringes made in China that aren’t cleared by the FDA for use in the U.S.

The manufacturers who were not issued the recent warning letters have also had problems, such as:

  • Foreign matter in syringes
  • Multiple needles breaking off in vials while drawing up vaccines
  • Medication delivering faster than it should
  • Cracked syringes

The FDA recommends healthcare providers, consumers, and suppliers in the U.S. to transition to products from another manufacturer as soon as possible. Healthcare providers can use the syringes as needed until they can switch to an alternative product. However, closely monitor the syringes for leaks, breaks, and other issues.

Glass syringes, pre-filled syringes, and syringes used for oral and topical uses are not part of the investigation, so they’re safe to continue using.

If you have any problems related to the use of plastic syringes manufactured in China, report them to the FDA’s Medwatch Adverse Event Reporting program.

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