Dive Brief:
- The Food and Drug Administration published an early alert last week about a potentially high-risk issue with certain lots of Medline’s fluid delivery sets with drip chambers.
- Medline, which recalled plastic syringes and endotracheal tubes last year, wrote to customers on Dec. 16 to request the removal of devices that could cause the over-administration of fluids.
- The FDA posted an early alert on Dec. 30. The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls.
Dive Insight:
Medline contacted customers after learning that it shipped some custom kits with fluid delivery sets that used the wrong drip chamber. The product should have a gray micro drip chamber. Some sets were shipped with a white macro drip chamber. Users should discard delivery sets with white macro drip chambers because of safety risks.
“The macro drip chamber delivers three times more fluid per drop than the micro drip chamber,” the FDA said in its early alert. “As a result, using a fluid delivery set with this incorrect component increases the risk of over-administration of fluids, which may result in swelling (edema), shortness of breath, increased blood pressure, and/or death.”
Medline has not reported any injuries associated with the issue.
Publishing an early alert allows the FDA to quickly share details of a company’s action while it collects the information needed to assign the recall to a risk category. Nearly four months elapsed between Medline alerting customers about its endotracheal tubes in early 2024 and the FDA publishing a Class I recall notice. The FDA posted the early alert 14 days after Medline wrote to customers about its fluid delivery sets.
The agency has published early alerts about devices sold by Baxter, Fresenius Kabi, Olympus and others since starting the pilot late last year.
