The FDA says Medline initiated additional recalls as the company grapples with issues surrounding syringes made in China.
Medline’s latest recalls aim to stop using affected products that include bulk unauthorized plastic syringes made in China and bulk plastic syringes made in China with performance testing failures. These add to last month’s recalls asking customers to stop using affected syringes contained in convenience kits.
In November 2023, the FDA warned of potential failures with plastic syringes manufactured in China. Those failures include leaks, breakage and other problems. The agency claimed that it received reports of quality issues associated with several Chinese syringe manufacturers.
On March 18, 2024, the FDA issued warning letters that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. to three companies: Jiangsu Shenli Medical Production, Medline Industries and Sol-Millenium Medical.
Zhejiang Longde and Shanghai Kindly, two more syringe makers, joined the original trio last month. Meanwhile, BD elected to step up domestic production in response to the import bans on those syringes in March.
The FDA says its recommendations remain unchanged related to the warnings on syringes made in China otherwise.
