FDA sends three warning letters in probe of plastic syringes made in China

In late 2023, the FDA commenced evaluating plastic syringes from China for quality issues, advising against their use due to reported problems. Warning letters were issued to Medline Industries and Sol-Millennium Medical after FDA inspections in December revealed violations related to unauthorized syringe distribution and quality system breaches.

Medline was found distributing syringes from Jiangsu Shenli Medical Production without proper clearance, while Sol-Millennium marketed substantially different syringes. The FDA listed nearly 60 unapproved models from both companies.

Medline's association with Jiangsu Caina Medical, highlighted by test failures and inadequate investigations, was also noted. FDA investigations are ongoing, with recipients expected to rectify violations promptly.

Transition away from syringes by Jiangsu Caina and unauthorized ones by Jiangsu Shenli is advised. If possible, consumers and healthcare organizations should avoid other plastic syringes made in China, according to the FDA.