The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2575-2020·Announced 2020-07-22

CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy with significant inaccuracy, 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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored at least 4.

Plain-English summary

CME America, LLC is recalling BodyGuard Microset infusion administration sets (REF: A120-003XS2YV). The recall involves 169,856 units distributed across 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 ranging from minus 42.8% to plus 17.5%, which exceeds the acceptable limit of plus/minus 13%. The use of these infusion pump systems could result in over-infusion or under-infusion of therapy.

Healthcare facilities and consumers who have these specific infusion sets should stop using them and contact CME America, LLC for further instructions on return or replacement.

The recalled product

Product
BodyGuard Microset, REF: A120-003XS2YV
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Administration Set
Hazard
Affected units
169,856

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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