The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2554-2020·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.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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"

Plain-English summary

CME America, LLC has issued a recall for the BodyGuard Microset (REF: A120-160XPS), an infusion administration set. The company is recalling 479,559 units because the devices may have a delivery inaccuracy ranging from minus 42.8% to plus 17.5%, which exceeds the acceptable limit of plus/minus 13%. This defect could result in the over-infusion or under-infusion of therapy when used with an infusion pump system.

The recall affects all lots within their expiry date. The 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 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 markets, specifically 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: A120-160XPS
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Administration Set
Hazard
Affected units
479,559

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 date

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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