CME America Recalls BodyGuard Microset Infusion Sets Due to Filter Defect
CME America is recalling BodyGuard Microset infusion sets because the installed filter may have the incorrect pore size. The recall affects 30,300 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential defect in a medical device used for IV therapy where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion sets intended for use with the BodyGuard Infusion Pump. The recall involves 5,800 infusion sets from lot 90829 and 24,500 from lot 16201. These products are used for maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.
The recall was initiated because the filter installed onto the tube set may have the incorrect pore size. This defect could potentially affect the filtration performance of the device.
The affected products were distributed nationwide in the United States, including in the states of Alaska, California, Illinois, Kansas, Massachusetts, Missouri, and South Dakota. No units were distributed outside the U.S. Consumers and healthcare providers should stop using the affected lots and contact CME America for further instructions.
The recalled product
- Product
- BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital…
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Sets
Distribution
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