Injured? Dial #WIN or #946 from your cellphone for your free consultation or call 1-800-LAW-NEED.
Call Us 24/7
( 1-800-529-6333 )
We are open & here for you

Class I Recall Designation for BodyGuard Infusion Pumps

May 11, 2020

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) upgraded CME America's recall of its BodyGuard Infusion pumps, along with the infusion sets, to a Class I recall. CME America is a wholly-owned subsidiary of Becton, Dickinson, and Co. The FDA's Class I recalled designation signifies to consumers that the FDA believes that continued use of the recalled medical devices presents a high likelihood that the patient could suffer severe adverse health consequences, including a fatal injury. After the FDA upgraded CME America's BodyGuard Recall to a Class I, CME America decided to remove all of its remaining BodyGuard pumps and infusion sets, and all of the existing products from the medical device market in the United States. CME America has not received any reports of adverse events or injuries to a patient because of the defects. *

CME America started its recall campaign for its infusion sets and BodyGuard pumps because of the chance that the devices would deliver an inaccurate amount of medication or fluids. The devices fluctuated between under-infusion, or delivery of medication at a rate slower than expected, and over-infusion, meaning that the rate of delivery was faster than expected. The delivery inaccuracy measured up to thirteen percent during inspections. 

In September, inspections measured the inaccuracy rate of under-infusion to be close to 50 percent in the CME America's Microset infusion kits when used in conjunction with the BodyGuard infusion pump. 

The current recall involves seven models and affects over 28,000 pumps and infusion sets. CME has asked all customers to dispose of the recalled devices. The company said that it would reimburse its customers for their losses. 

CME designed the BodyGuard pump and infusion set to deliver medicine and fluids to patients in an outpatient setting. CME America's BodyGuard pump sets are often used to deliver chemotherapy, pain medication, antibiotics, and nutrition, as necessary.

Put Our Law Firm's Legal Experience to Work For You! We Know What It Takes To Win!™

While we hope you are safe and never need our services, we are here to help you if you are involved in any type of accident or just have a question.  Call Montlick & Associates, Injury Attorneys, for your free consultation today. Our law firm has been representing those who suffer serious injuries for over 36 years and our attorneys have recovered billions of dollars for our clients. We Know What It Takes To Win!™

No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us nationwide 24 hours day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333), or simply dial #WIN (#946) from your mobile phone. You can also visit us online at and use our Free Case Evaluation Form or Free 24-hour live chat.


Category: Product Liability

Please Note:
Many of our blog articles discuss the law. All information provided about the law is very general in nature and should not be relied upon as legal advice. Every situation is different, and should be analyzed by a lawyer who can provide individualized advice based on the facts involved in your unique situation, and a consideration of all of the nuances of the statutes and case law that apply at the time.