Baxter announced a voluntary recall of 4 lots of intravenous (IV) solutions due to the potential for leaking containers and particulate matter. The Company received 2 complaints for leaking containers and 1 complaint each for 3 lots due to particulate matter.
The affected products are:
- 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container (Lot # P337857)
- 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container (Lot # P328997)
- Metronidazole Injection, USP 500mg/100mL (Lot # P339135)
- Clinimix E 5/15 (5% AA w/Electrolytes in 15% Dextrose w/Calcium) (Lot # P333930)
A leak in the container could lead to contamination of the solution. If this is not discovered prior to administration, it can result in a bloodstream infection, worsened patient condition or other serous health consequences. In addition, administration of a product containing particulate matter without in-line filtration, can lead to blockage of blood vessels, which can result in stroke, heart attack, organ damage or death. Possible allergic reactions, local irritation, and inflammation in tissues and organs may occur.
Eleven units of one lot of 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container were confirmed. An investigation identified the root cause as a mechanical issue that affected a single machine. Another unit in a separate lot of 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container was found to contain a piece of cardboard particulate matter. The unit of Metronidazole Injection was found to contain cloth fiber particulate matter, and a unit from Clinimix E 5/15 was found to contain a small fragment of dried skin particulate matter.
Recalled products should be returned to Baxter for credit. Unaffected lots are also available for replacement.
For more information call (888) 229-0001 or visit FDA.gov.