Class I Recall Designation for BodyGuard Infusion Pumps
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.
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