CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy
CME America is recalling 6,320 BodyGuard Microset infusion sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, and the rubric mandates a score of at least 4 for any FDA Class I or USDA Class I recall.
Plain-English summary
CME America, LLC is recalling 6,320 units of the BodyGuard Microset with Filter and Manual Priming Valve (REF: A120-112XSFV). The recall is due to a defect where the infusion administration sets may have a delivery inaccuracy exceeding plus or minus 13%, with observed ranges from minus 42.8% to plus 17.5%.
The use of these infusion pump systems could result in the over-infusion or under-infusion of therapy. The affected units were distributed in all 50 U.S. states, the District of Columbia, Canada, and the United Kingdom. All lots within their expiry dates are included in this recall.
Healthcare facilities and consumers should stop using the affected BodyGuard Microset infusion sets immediately. CME America, LLC is the firm responsible for the recall.
The recalled product
- Product
- BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
- Manufacturer
- CME America, LLC
- Affected units
- 6,320
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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