Company Announcement Date: September 09, 2019

FDA Publish Date: September 10, 2019

Product Type: Medical Devices

General Hospital & Personal Use

Reason for Announcement: Potential for leaking of the IV bag at the chamber divider rod

Company Name: The Metrix Company

Brand Name: Metrix, Baxter

Product Description: Empty IV flexible containers (bag)

The Metrix Company of Dubuque, Iowa is recalling specific lots of the empty IV flexible containers (bag) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names, due to the potential for leaking of the IV bag at the chamber divider rod, which could result in a serious infection to the patient.

These bags are used for use in an intravenous admixture program, to store and deliver intravenous parenteral admixtures to patients. The empty bag is filled with parental admixtures by a healthcare provider (e.g. licensed pharmacist) under normal pharmacy conditions, e.g. laminar flow hood.

These products were supplied to distributors throughout the United States and Canada from 11/01/2016 thorough 07/29/2019.

The product code and lot number can be identified on the outer box label on the cardboard carton and on the outer bag label. The complete product identifier consists of a 5-digit product code with a unique 5-digit lot number after the hyphen.

The recall was initiated after receipt of eight complaints of leaking bags, in which the leak occurred near the divider rod and channel, when the rod was being removed. Use of the defective product, with a breach of the sterile barrier could result in serious infection to the patient. Subsequent investigation indicates the problem was caused by the assembly machine malfunction, creating additional stress on the rod, channel and bag film resulting in a potential to cause a material anomaly that is concealed until the rod is removed at the point of use.

No reports of death, illnesses or injuries have been reported to date from the use of this product.

Metrix is working with distributors and consumers to facilitate prompt return and replacement of the product affected by this recall, to minimize impact on patient therapy. Pharmacies who have purchased EVA Dual Chamber containers (bags), are urged to contact their distributor for further instructions on the return, see table for a complete list of product codes and lot numbers affected.

Therefore:

If the recalled product is intended for immediate use, and there is no alternative, your Healthcare Provider will make a determination on the risk/benefit associated with you using the potentially non-sterile product.

If product is not for immediate use, immediately discontinue use of the product and contact the place of purchase or pharmacy for further instructions for returning and replacing the affected product.

Consumers with questions about this recall, including facilitating replacement product, may contact The Metrix Company at 1-800-752-3148, Monday through Friday, 8:00 AM to 5:00 PM Central time or email; recallcoordinator@metrixco.com. The Metrix Company regrets any inconvenience this may cause and is committed to patient safety and customer satisfaction.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.