The Recall Desk
HighFDA (Devices)·Z-2574-2020·Announced 2020-07-22

CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.

What this means for you

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 source text describes a risk of harm (over- or under-infusion) where injury has not yet been reported. Although the agency classification is Class I, the specific hazard criteria for 'risk-of-harm products where injury has not yet been reported' aligns with a score of 3 in the absence of reported fatalities or hospitalizations.

Plain-English summary

CME America, LLC has issued a recall for the BodyGuard Microset infusion administration set (REF: A100-163XSL). The company is recalling 28,600 units of this product. All lots within their expiry dates are included in this recall action.

The recall was initiated because the infusion administration sets may have a delivery inaccuracy over plus/minus 13%. The reported range of inaccuracy extends from minus 42.8% to plus 17.5%. Using the infusion pump system with these affected sets could cause over-infusion or under-infusion of therapy.

The recalled products were distributed across the United States, including California, Indiana, Louisiana, Missouri, Florida, Illinois, Maine, Minnesota, Colorado, Virginia, Oklahoma, Nebraska, Georgia, Alabama, Kentucky, Iowa, Mississippi, Idaho, Texas, South Carolina, Ohio, South Dakota, Nevada, Michigan, Wyoming, North Carolina, Pennsylvania, Tennessee, Kansas, New Jersey, Oregon, Arkansas, New Mexico, Massachusetts, New York, Washington DC, Rhode Island, Maryland, Washington, Wisconsin, Arizona, New Hampshire, Utah, Hawaii, Alaska, Montana, North Dakota, Vermont, and Connecticut. The products were also distributed internationally to Canada and the United Kingdom.

Consumers who possess this product should stop using it immediately and contact CME America, LLC for further instructions regarding returns or replacements.

The recalled product

Product
BodyGuard Microset, REF: A100-163XSL
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Administration Set
Hazard
Affected units
28,600

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 →

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