The Metrix Co. is recalling specific lots of the empty IV flexible containers due to possible leakage that can cause serious infection to the patients.
The bags, marketed as Metrix Secure EVA Dual Chamber and Baxter ExactaMix, are used to store drug mixtures. The Dubuque, Iowa-based private company supplies empty bags that are later filled by a healthcare provider such as a licensed pharmacist.
The lots were recalled based on eight complaints of these bags leaking near the divider rod and channel when the rod was being removed at the point of use. A malfunction in the assembly machine caused this problem, The Metrix noted in its Sept. 9 announcement.
The U.S. Food and Drug Administration has asked patients to not to use the drugs in a leaked bag and to immediately inform their healthcare provider. The only exception is an immediate need to use the recalled product, for which the healthcare provider will make a decision regarding the use of the possibly contaminated drug based on risk and benefit to the patient.
