The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2553-2020·Announced 2020-07-22

CME BodyGuard BodySet Infusion Sets Recalled for Delivery Inaccuracy

CME America is recalling BodyGuard BodySet 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

CME America, LLC is recalling 3,250 units of BodyGuard BodySet infusion administration sets (REF: A120-160SAS). The recall was initiated 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%.

The use of these infusion pump systems could result in the over-infusion or under-infusion of therapy. The affected units were distributed in 48 U.S. states, the District of Columbia, Canada, and the United Kingdom. All lots within the expiry date are included in this recall.

This is an FDA Class I recall. Healthcare facilities and consumers should stop using the affected infusion sets immediately and contact CME America for instructions on return or replacement.

The recalled product

Product
BodyGuard BodySet, REF: A120-160SAS
Manufacturer
CME America, LLC
Category
Medical Device — Infusion Sets
Hazard
Affected units
3,250

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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