Baxter International is voluntarily recalling intravenous solution due to leaking containers and the potential for particulate matter.
Baxter International is voluntarily recalling intravenous (IV) solution due to leaking containers and the potential for particulate matter.
Two complaints were made regarding leaking containers, and 1 customer reported particulate matter in 3 lots, according to an FDA press release.
Baxter reported no adverse events related to these issues; in each case, the problems were identified before administering the solution to patients.
Leaking containers could lead to contamination, which could cause patients to develop a bloodstream infection.
An investigation into the leaking containers found the cause was a mechanical issue that affected 1 machine during a shift. The issue has since then been resolved, according to Baxter.
Injecting IV liquid that contains particulate matter could lead to a blockage in blood vessels. In turn, individuals may experience stroke, heart attack, or damage to their organs. Patients are also at risk of having an allergic reaction.
The following products are affected by the recall, according to the FDA:
A fragment of cardboard particulate matter was found in a unit from lot P328997, cloth fiber matter was found in a unit from lot P339135, and a “small fragment of dried skin” particulate matter was found in a unit from lot P333930.
Baxter has notified its customers of the recall and advises individuals to avoid using products from the specified lots. Recalled items can be returned to Baxter in exchange for a credit.
The FDA encourages health care professionals and patients to report adverse effects to the MedWatch Adverse Event Reporting Program.