The agency has told U.S. suppliers, healthcare providers and consumers to avoid plastic syringes from Jiangsu Caina Medical Co., Jiangsu Shenli Medical Production Co., Shanghai Kindly Enterprise Development Group Co. and Zhejiang Longde Pharmaceutical Co. If possible, the FDA recommends using syringes not manufactured in China because of quality concerns.
As of July 18, the FDA has also sent warning letters to Cardinal Health, Medline Industries and Sol-Millennium Medical, alleging unapproved device violations.
Since late November, the agency has been investigating reports of plastic syringes breaking and leaking. The problem might be tied to different product dimensions that make the plastic syringes incompatible with infusion pumps, the FDA has previously said.
In March, the agency said the issue is “more widespread than originally known,” but its latest update says there is enough supply outside of China to meet current demand.
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