CME BodyGuard Microset Infusion Sets Recalled for Fluid Under-Delivery
CME America is recalling BodyGuard Microset infusion sets because they may under-deliver fluids when used with specific infusion pump systems.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I'. Per the rubric, FDA Class I recalls are classified as Critical (Score 5) because they represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
CME America, LLC is recalling BodyGuard Microset infusion sets (REF A120-003XYVA) because the tubing may result in the under-delivery of fluids when used with a specific infusion pump system. The affected product is a sterile, ethylene oxide-sterilized infusion set with 150-inch tubing and an approximate prime volume of 8 ml, designed to transfer medication and fluids intravenously.
The recall involves 69,400 infusion sets distributed in the United States (California, Ohio, Pennsylvania, and Texas) and Canada. The specific lot numbers affected are 10636, 10653, 12117, 12836, 13156, 13279, 13656, 13978, 14057, 14188, 14545, 14790, 14966, 15073, 19486, 19490, 19492, 19834, 16173, 15277, 15434, and 15802.
Healthcare providers and consumers should stop using the affected infusion sets and contact CME America, LLC for further instructions or a replacement. The U.S. Food and Drug Administration has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Set
- Hazard
- Affected units
- 69,400
Distribution
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