Agency classClass IOur severity:Critical FDA (Devices)·Z-2559-2020·Announced 2020-07-22

CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that may cause over-infusion or under-infusion of therapy.

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, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A120-112XSFK). The recall involves 1,273,892 units. The product was distributed to 48 U.S. states, the District of Columbia, Canada, and the United Kingdom.

The recall was initiated because the infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy.

The agency classifies this as a Class I recall. Healthcare providers and consumers should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product: BodyGuard Microset, REF: A120-112XSFK
Manufacturer: CME America, LLC
Category: Medical Device — Infusion Administration Sets
Hazard: delivery-inaccuracy
over-infusion
under-infusion
Affected units: 1,273,892

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots within expiry

Distribution

Distributed in 49 states:

Part of a larger recall action

This product is one of 37 recalled by CME America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Same manufacturer · CME America, LLC

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Same hazard · delivery inaccuracy