Baxter International is voluntarily recalling four lots of intravenous solutions due to the potential for leaking containers and particulate matter.
Baxter says it was made aware of the issue as the result of two complaints for leaking containers and one customer complaint for three lots for particulate matter. No adverse events associated with these incidents have been reported to Baxter to date, the company says.
The company adds that leaking containers were confirmed in 11 units of one lot of 0.9 percent sodium chloride injection, 100 mL in Mini-Bag Plus Container, and a subsequent investigation identified the root cause as a mechanical issue that affected one machine during a single shift. The mechanical issue has since been remedied.
The company says a fragment of cardboard particulate matter was found in single unit in a separate lot of 0.9 percent sodium chloride injection, 100 mL in Mini-Bag Plus Container. A unit of metronidazole injection 500mg/100mL was found to contain cloth fiber particulate matter. Also, a unit of Clinimix E 5/15 was found to contain a small fragment of dried skin particulate matter.