The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2570-2020·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 fluids with an inaccuracy exceeding plus/minus 13%, risking over- 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I. According to the rubric, an FDA Class I classification mandates a severity score of at least 4 (Severe) regardless of other factors, as it indicates a situation where use could cause serious adverse health consequences or death.

Plain-English summary

CME America, LLC has issued a recall for the BodyGuard Microset w/ Non-Vented Spike Connector (REF: A100-163XEBS). The company is recalling approximately 500 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%. Specifically, the flow rate deviation has been observed to range from minus 42.8% to plus 17.5%. This defect means that when used with an infusion pump system, patients could experience over-infusion or under-infusion of their prescribed therapy.

The affected products were distributed in the United States across numerous 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 D.C., Rhode Island, Maryland, Washington, Wisconsin, Arizona, New Hampshire, Utah, Hawaii, Alaska, Montana, North Dakota, Vermont, and Connecticut. The products were also distributed in foreign countries, specifically Canada and the United Kingdom.

Consumers who possess these infusion sets should stop using them immediately and contact CME America, LLC for further instructions on how to return or dispose of the product.

The recalled product

Product
BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Administration Set
Hazard
Affected units
500

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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