Nearly four months after the FDA said it was investigating reports of China-made syringes breaking and leaking, the agency confirmed the quality issue and found the problem is "more widespread than originally known."
On March 18, the FDA sent warning letters to Medline Industries and Sol-Millennium Medical for selling unauthorized plastic syringes, and China-based manufacturer Jiangsu Shenli Medical Production was also warned. In the letters to Medline and Sol-Millennium Medical, the agency demanded the companies address quality system regulation violations.
After manufacturers made changes to product dimensions, the plastic syringes were incompatible with infusion pumps and were faulty with providing correct medication doses. In late November, healthcare providers were told to avoid plastic syringes made in China because of reports of the products cracking. The FDA said March 19 it is upholding this recommendation during the ongoing investigation.
Jiangsu Caina Medical Co., another manufacturer based in China, was cited in Medline's warning letter because of "unexpected and unexplained failures" with its syringes, the FDA said.
The U.S. supply of plastic syringes is sufficient without these products, so a shortage is unlikely, the agency said.