The U.S. Food and Drug Administration has warned health care giant Cardinal Health over sales of imported plastic syringes made by Jiangsu Shenli Medical Production Co. Ltd. that don't meet device quality requirements.
In an April 24 letter to Steve Mason, president and CEO of Dublin, Ohio-based Cardinal Health, FDA officials said that the firm's "failure to ensure the syringes you are including in convenience kits … have 510(k) clearance has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that there is reasonable assurance of the safety … of these modified devices."
FDA has been in communication with Cardinal Health on the matter since late 2023. In December, FDA officials inspected a Cardinal Health site in Waukegan, Ill.
On April 10, all plastic syringes made by Jiangsu Shenli were banned from entering the U.S. by an FDA order. At that time, FDA also updated recommendations to U.S. suppliers of plastic syringes, consumers, health care providers and facilities to "immediately transition away from using all models of plastic syringes, including 5 mL luer lock syringes, manufactured by [Jiangsu Shenli] unless use of these syringes is absolutely necessary until you can complete the transition."
In March, FDA sent warning letters to medical suppliers amid its evaluations of quality and performance issues in plastic syringes made in China. It announced in November 2023 that it was monitoring reports of safety issues associated with "several Chinese manufacturers of syringes." FDA is "taking steps to refuse entry of these devices into the United States" until violations are addressed by the companies, it said in a March 11 letter to Jiangsu Shenli.
FDA found the company, based in Changzhou, marketed plastic piston syringes in the U.S. without marketing clearance or approval. In the April 24 letter, FDA officials said that Cardinal Health "should take prompt action to address any violations identified in this letter."
"Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice," they added. "These actions include, but are not limited to, seizure, injunction, and civil money penalties."
FDA officials said in a separate news release that the agency "will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available."
When reached by Plastics News, a Cardinal Health spokesman declined to comment on the April 24 warning letter. He referred to a Feb. 2 news release from Cardinal Health in which the firm, in conjunction with the FDA, issued a voluntary product removal of all sizes of its Monoject-brand syringes and Monoject Enteral syringes which are color-coded purple to denote enteral feeding only.
The February recall expanded Cardinal Health recall actions from September and December 2023. "It is our intention that expanding the recall action … will reduce confusion and create a simplified course of action for our customers as we continue to work with the FDA, the syringe manufacturer and pump manufacturers to reintroduce" the syringes, officials said in the Feb. 2 release.
Cardinal Health is one of the largest medical firms in the U.S. The firm is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products and a provider of performance and data solutions for health care facilities.
Cardinal Health employs 48,000 and posted sales of $205 billion in 2023. The firm serves almost 90 percent of U.S. hospitals, more than 60,000 U.S. pharmacies and more than 10,000 specialty physician offices and clinics.