Baxter IV Solutions (Select Lots): Recall - Potential for Leaking Containers and Particulate Matter

0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container
Metronidazole Injection, USP 500mg/100mL
Clinimix E 5/15 (5% AA w/Electrolytes in 15% Dextrose w/Calcium)

AUDIENCE: Risk Manager, Nursing, Infectious Disease

ISSUE: Baxter is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. See Firm Press Release for affected lots.

Leaking containers could result in contamination of the solution. If not detected, this could lead to a bloodstream infection, worsened patient condition or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack, damage to other organs such as the kidney or liver, or death. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

BACKGROUND: Baxter was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to particulate matter.

RECOMMENDATION: Customers were notified via letter that they should not use product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm483215.htm