Cardinal Health (NYSE:CAH) has initiated a U.S. recall of its Monoject Flush prefilled saline syringes due to an issue with the reintroduction of air.
Dublin, Ohio-based Cardinal Health on Aug. 4 recalled approximately 267 million Monoject Flush devices because they have been found to reintroduce air into the syringe after the air has been expelled, which can potentially result in the injection of air into blood vessels, creating the potential for air embolism leading to serious adverse health outcomes or death.
The company received 37 reports of the plunger pulling back, with no injuries reported to date. The recall was a voluntary action by the company, it said, and it notified the FDA of the action.
The affected products include the 12mL syringe & 10 mL saline fill (SKU:8881570121), the 12mL syringe & 3mL saline fill (SKU:8881570123) and the 12mL syringe & 5mL saline fill (SKU:8881570125). The recall applies to all lots of the products manufactured from July 2019 to June 2021 and distributed between those same dates, according to a news release.
Cardinal Health’s Monoject 3mL syringe & 2.5mL saline fill (SKU:8881570300) was not affected by the recall and will be available until inventory is depleted.
