Company Recalls TPN Bags Because of Leak and Infection Risk
Bags used to store and administer total parenteral nutrition (TPN) are being recalled because of leaks near the divider rod and channel when the rod is removed, the Metrix Company of Dubuque, IA, announced (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/metrix-company-dubuque-iowa-recalling-specific-lots-empty-iv-flexible-containers-bag-marketed-under?utm_campaign=FDA%20MedWatch%20-%20Metrix%20Secure%20EVA%20Dual%20Chamber%20and%20Baxter%20ExactaMix%20by%20Metrix%20Company%3A%20Recall&utm_medium=email&utm_source=Eloqua) on September 9, 2019.
Only specific lots (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/metrix-company-dubuque-iowa-recalling-specific-lots-empty-iv-flexible-containers-bag-marketed-under?utm_campaign=FDA%20MedWatch%20-%20Metrix%20Secure%20EVA%20Dual%20Chamber%20and%20Baxter%20ExactaMix%20by%20Metrix%20Company%3A%20Recall&utm_medium=email&utm_source=Eloqua) of the empty IV flexible bag marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names are affected. The bags were distributed in the United States and Canada from November 1, 2016–July 29, 2019.
Metrix voluntarily issued the recall after receiving eight reports of leakages, which, if breaching the sterile barrier, could lead to infection, although no illnesses have been reported. Pharmacies are instructed to remove the bags from distribution and await return instructions.
Because the bags are used for TPN in the home, patients should be advised to immediately inform their healthcare providers if they notice a leaking bag. If the bag is leaking, they should not infuse it. If they have bags from the affected lots at home, they should contact their pharmacy for return instructions.
Consumers should contact Metrix with any questions at 800-752-3148, Monday–Friday, 8 am–5 pm Central Time or email recallcoordinator@metrixco.com (mailto:recallcoordinator@metrixco.com). Healthcare providers should report adverse reactions or quality problems with the bag to the U.S. Food and Drug Administration’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.