In two import alerts posted in late March and early April, the FDA said all of Jiangsu Shenli’s piston syringes are subject to detention without physical examination.
The agency first raised issues with China-made plastic syringes in late November after receiving reports of the products breaking and leaking. During its investigation, Medline Industries and Sol-Millennium Medical received warning letters, and China-based Jiangsu Caina Medical Co. was cited for “unexpected and unexplained failures” with its syringes, the FDA said.
“We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance,” the agency said April 10.
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