CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (over- or under-infusion of therapy) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
CME America, LLC is recalling 29,720 units of BodyGuard Microset infusion administration sets (REF: A120-160GCFA). The recall covers all lots within their expiry dates.
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 plus/minus 13% threshold. This inaccuracy could result in the over-infusion or under-infusion of therapy when used with an infusion pump system.
The affected products were distributed in 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, District of Columbia, Rhode Island, Maryland, Washington, Wisconsin, Arizona, New Hampshire, Utah, Hawaii, Alaska, Montana, North Dakota, and Vermont) and in Canada and the United Kingdom. Consumers and healthcare providers should stop using these specific infusion sets and contact CME America, LLC for further instructions.
The recalled product
- Product
- BodyGuard Microset, REF: A120-160GCFA
- Manufacturer
- CME America, LLC
- Category
- Medical Device — Infusion Sets
- Affected units
- 29,720
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
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.
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