UPDATED: Insect Parts Found in IV Solution Prompts Baxter Recall
Baxter International, Inc. has announced a recall due to the potential presence of an insect in two lots of intravenous (IV) solutions. In the announcement, the company classifies the insect as "particulate matter."
Injecting a product containing particulate matter may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
The issue was identified due to a consumer complaint. As the recall was announced prior to patient administration, no adverse events have been reported.
For identifying information for the two lots, including product code, description, and expiration date, see the Food and Drug Administration (FDA) release.
The affected lots were distributed between June 6, 2015 and December 16, 2015.
Baxter is directing customers not to use the product from the recalled lots. Unaffected lots of product are available for replacement. Recalled product should be returned for credit by contacting Baxter Healthcare Center for Service at (888) 229-0001.
Consumers with questions about the recall can contact Baxter by phone at (800) 422-9837 or by email at email@example.com.
Update: Baxter has announced a recall for additional solution due to the same issue. The recall applies to one lot of Sodium Chloride Irrigation, 500 mL. For identifying information, see the FDA release. The lot was distributed between November 12, 2015 and January 11, 2016.