West is committed to safeguarding the health and safety of patients who use our products and services. Quality product system controls are designed to ensure compliance with our high standards and applicable cGMPs, ISO standards and regulatory requirements. Listed below are any recent product performance updates that have been communicated to customers.
See below for the latest customer alerts and notices.
Vial2Bag®, Vial2Bag DC 13mm, and Vial2Bag DC 20 mm Device Recall: January 2019
West has issued a voluntary recall of the Vial2Bag; Vial2Bag DC 13mm; and Vial2Bag DC 20 mm devices, manufactured by our wholly-owned subsidiary in Israel (formerly known as MediMop Medical Projects Ltd.), to all end-user facilities. The recall is due to reports that described drug dosage being unpredictable or variable when administered with the Vial2Bag DC 13 mm device. With an ongoing internal investigation of the Vial2Bag DC 13 mm device underway, and in an abundance of caution for patient safety, we are recalling the three devices while we continue our root cause analysis. Ensuring the quality of our products and the safety of the patients utilizing them is our top priority. We will continue to work to understand the reports and, in consultation with the FDA and other regulatory bodies, work to resupply the market as soon as is reasonably possible.