WASHINGTON, D.C. — Infusion Options, Inc. voluntarily recalled all sterile products that have not expired to date because the company cannot assure that their products are sterile. Infusion Options, Inc. made the announcement on June 18, 2019, and the U.S. Food and Drug Administration (FDA) followed up with an announcement on June 20, 2019. Infusion Options, Inc. recalled all of its products “to the hospital level,” meaning that all items within the chain of distribution, including hospitals, must immediately stop using the recalled products. The products subject to the recall announced by Infusion Options, Inc. does not include medical products sold to the general public.
Infusions Options, Inc has not received any notifications about health complications or injuries regarding its products. The FDA stated that before using any medical equipment, healthcare professionals believe to be sterile that ultimately is not sterile is a huge health risk. The patient could contract a severe and life-threatening infection if medical professionals use non-sterile products on a patient when the medical professional intends to use a sterile medical product.
Infusion Options, Inc. indicated that it distributed the defective sterile equipment to a hospital in Brooklyn, New York. The FDA recall announcement did not specify which hospital received the faulty products. Infusion Options, Inc. asked that all healthcare professionals who received products labeled as sterile from Infusion Options, Inc. that have not expired to return the unused good to the manufacturer immediately for destruction.
Infusion Options, Inc. said that it is contacting its customers by email and letter to notify them about the recall and advise them how to rectify the situation. Infusion Options, Inc. did not state how it learned about the defective products or say how they might cure the defects.
Although the FDA is aware of the recall and helped publicize the announcement, the FDA explicitly exclaims any endorsement of any company.
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