The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2581-2020·Announced 2020-07-22

CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion 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 is recalling BodyGuard Microset with Male Luer Connectors (REF: A100-163XEBF) due to a defect in the infusion administration sets. The affected devices may exhibit delivery inaccuracies ranging from minus 42.8% to plus 17.5%, which exceeds the acceptable limit of plus or minus 13%.

The recall covers 8,016 units distributed across 49 U.S. states, the District of Columbia, Canada, and the United Kingdom. All lots within their expiration dates are affected. The use of these infusion pump systems could result in the over-infusion or under-infusion of therapy to patients.

Healthcare facilities and consumers should stop using the affected BodyGuard Microset infusion sets immediately. CME America is the recalling firm responsible for managing the recall process.

The recalled product

Product
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Administration Sets
Hazard
Affected units
8,016

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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